−Removed: We are a life sciences company that has developed next-generation, ultra-sensitive digital immunoassay platforms that advance precision health for life sciences research and diagnostics.
+Added: We are a life sciences company that has developed next-generation, ultra-sensitive digital immunoassay platforms that advance life sciences research and diagnostics.
Our platforms are based on our proprietary digital “Simoa” detection technology.
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We believe this greater insight will enable the development of novel therapies and diagnostics and facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention.
−Removed: We believe that our Simoa platforms are among the most sensitive commercially available multiplex protein detection platforms and significantly advance ELISA technology, which has been the industry standard for protein detection for over 40 years.
−Removed: Furthermore, we believe the HD-X is the most sensitive commercially available automated multiplex protein detection platform .
+Added: We believe that our Simoa platforms are among the most sensitive commercially available multiplex protein detection platforms and significantly advance enzyme-linked immunosorbent assay (ELISA) technology, which has been the industry standard for protein detection for over 45 years.
Proteins are complex molecules that are required for the structure, function and regulation of the body’s tissues and organs, and are the functional units that carry out specific tasks in every cell.
The human body contains approximately 20,000 genes, each of which can produce multiple proteins.
−Removed: It is estimated that these 20,000 genes can produce over 100,000 different proteins, of which at least 10,000 are known to be secreted in blood.
−Removed: Researchers and clinicians rely extensively on protein biomarkers for use as research and clinical tools.
+Added: It is estimated that these 20,000 genes can produce over 100,000 different proteins, of which 10,000 – 15,000 are estimated to be secreted in blood.
+Added: Proteins are considered to be the best analytes – providing the most real-time picture of disease, and researchers and clinicians rely extensively on protein biomarkers for use as research and clinical tools.
However, normal physiological levels of many proteins are not detectable in easily accessible blood samples using conventional, analog immunoassay technologies, and many of these technologies can only detect proteins once they have reached levels that reflect more advanced disease or injury.
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Our Simoa platforms have achieved significant scientific validation and commercial adoption.
−Removed: Simoa technology has been cited in approximately 1,600 scientific publications in areas of high unmet medical need and research interest such as neurology, oncology, cardiology, infectious disease and inflammation.
−Removed: Our growing customer base is comprised of over 1,120 customers across our end markets and includes 22 of the 25 largest biopharmaceutical companies.
+Added: Simoa technology has been cited in over 2,000 scientific publications in areas of high unmet medical need and research interest such as neurology, oncology, cardiology, infectious disease and inflammation.
+Added: Our growing customer base is comprised of over 1,300 customers across our end markets.
+Added: Restructuring and Strategic Re-Alignment
+Added: Following a strategic review and assessment of our operations and cost structure, in the third quarter of 2022 we announced a plan of restructuring and strategic re-alignment (the Restructuring Plan).
+Added: As part of this plan, we began an assay redevelopment program with the ultimate objective of improving our ability to manufacture and deliver high-quality assays at scale.
+Added: The Restructuring Plan aligns our investments to best serve the needs of customers, focuses innovation efforts on key platforms and provides the foundation for our entry into translational pharma and clinical markets, which we believe will be required to access new growth categories.
+Added: The Restructuring Plan included the elimination of 119 positions and other cost-saving measures.
+Added: The workforce reduction was substantially completed by the end of the third quarter of 2022.
Our Products and Services
−Removed: Our proprietary Simoa technology is based on traditional enzyme-linked immunosorbent assay (ELISA) technology, which has been the most widely used method of detection of proteins for over 40 years.
−Removed: Given our target customers’ familiarity with the core ELISA technology, we believe this offers us a significant competitive advantage.
+Added: Our proprietary Simoa technology is based on traditional ELISA technology, which has been the most widely used method of detection of proteins for over 45 years.
+Added: Given our target customers’ familiarity with the core ELISA
+Added: technology, we believe this offers us a significant competitive advantage.
Our Simoa bead-based platform differs, however, from conventional ELISA in its ability to trap single molecules in tiny microwells, 40 trillionths of a milliliter, that are 2.5 billion times smaller than traditional ELISA wells, allowing for an analysis and digital readout of each individual molecule, which is not possible with conventional ELISA technology.
−Removed: This ability is the key to our bead-based technology’s unprecedented sensitivity.
−Removed: In addition, in January 2018, we acquired Aushon BioSystems, Inc.
−Removed: (Aushon) and its proprietary sensitive planar array detection technology.
−Removed: Leveraging our proprietary sophisticated Simoa image analysis and data analysis algorithms, we further refined this planar array technology to provide the same Simoa sensitivity found in our Simoa bead-based platform.
−Removed: We currently offer the
−Removed: following three Simoa instruments, which we believe are among the most sensitive multiplex protein detection platforms commercially available today:
+Added: Leveraging our proprietary sophisticated Simoa image analysis and data analysis algorithms, we have also developed a planar array technology to provide sensitivity similar to that found in our Simoa bead-based platform.
+Added: We currently offer the following three Simoa instruments, which we believe are among the most sensitive multiplex protein detection platforms commercially available today:
We commercially launched our HD-X instrument in the second half of 2019.
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The current menu of Simoa planar array reagent kits includes approximately 115 biomarkers ranging from 1-10 analytes per assay in the areas of immunology and oncology research.
−Removed: We intend to continue to increase the number of Simoa biomarker assays across our platforms.
In addition, both the bead-based platform and the planar array platform allow ease and flexibility in assay design, enabling our customers to develop their own in-house assays, called “homebrew” assays.
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The Accelerator Laboratory provides customers with access to Simoa technology and supports multiple projects and services, including sample testing, homebrew assay development and custom assay development.
−Removed: To date, we have completed over 1,700 projects for approximately 400 customers from all over the world using our Simoa platforms.
−Removed: In addition to being an important source of revenue, we have also found the Accelerator Laboratory to be a significant catalyst for placing additional instruments, as a number of customers for whom we have provided contract research services have subsequently purchased an instrument from us.
−Removed: In view of the COVID-19 pandemic, in 2020 we adjusted our operations to expand capacity in our Accelerator Laboratory to support customers whose operations have been disrupted and to sustain clinical trials.
−Removed: We also determined that our cytokine assay technology could provide researchers with important and differentiated tools to study disease progression, cytokine release syndrome, and patient-treatment response in the fight against COVID-19, and began developing a SARS- CoV-2 semi-quantitative IgG assay and a SARS-CoV-2 antigen detection assay and prototyping a high-definition multiplex SARS-CoV-2 serology assay.
−Removed: In December 2020, the United States Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for our Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test, and in January 2021, the FDA issued an EUA for our Simoa SARS-CoV-2 N Protein Antigen Test, each of which is run on our HD-X instrument.
−Removed: In September 2021, the FDA expanded the EUA for our Simoa SARS-CoV-2 N Protein Antigen Test to include testing with nasal swabs and saliva and for asymptomatic serial testing with nasal swab samples.
−Removed: We are exploring extending the test to home-based sample collection and pooling to enable larger scale testing.
−Removed: In August 2019, we completed the acquisition of UmanDiagnostics AB (Uman), a company located in Umeå, Sweden, that supplies neurofilament light (Nf-L) antibodies and Nf-L ELISA kits.
−Removed: Uman’s Nf-L antibodies are widely recognized by researchers and biopharmaceutical and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
−Removed: Since we commercially launched the first assay that could reliably measure Nf-L in blood using Uman’s antibodies and our Simoa technology in 2017, Nf-L has seen dramatic growth as a neurological biomarker.
−Removed: This innovation allowed research, previously limited primarily to cerebrospinal fluid (CSF), to expand significantly and has led many of the world’s foremost neurology researchers and clinicians to conclude that Nf-L may be one of the most clinically relevant
−Removed: brain biomarkers available today.
−Removed: Despite significant efforts by us and others to identify or develop an alternative source of antibodies, we believe the Uman Nf-L antibodies remain the best-in-class for highly sensitive and specific Nf-L detection in serum or plasma.
−Removed: The superiority of the Uman antibodies is evidenced by the fact that, to date over 600 publications relating to the detection of Nf-L in serum or plasma have used the Uman antibodies.
−Removed: The Uman acquisition s ecured the Nf-L antibody supply critical to our industry-leading ultrasensitive Simoa Nf-L assays and services, provided us with additional revenue opportunities via the sale of the Nf-L antibodies and Nf-L ELISA kits, and positioned us to capitalize on significant growth opportunities with Nf-L applications in Alzheimer’s disease, multiple sclerosis, and other neurodegenerative conditions.
−Removed: We sell our instruments, consumables and services to the life science, pharmaceutical and diagnostics industries through a direct sales force and support organizations in North America and Europe, and through distributors or sales agents in other select markets.
−Removed: In addition, we sell Uman’s Nf-L antibodies and Nf-L ELISA kits directly, and in conjunction with a distributor worldwide.
−Removed: We have an extensive base of customers in world class academic and governmental research institutions, as well as pharmaceutical, biotechnology and contract research companies, using our technology to gather information to better understand human health.
−Removed: Our Market Opportunities
−Removed: Our commercial strategy is to pursue the application of our Simoa technology to the life science research/drug trial, diagnostics and precision health screening markets.
−Removed: Life Science Research/Drug Trial Markets
−Removed: Our initial target market is the large and growing life science research and drug trial markets, which we sometimes refer to collectively as the translational market.
−Removed: We have chosen these markets to target initially because we believe there is reduced regulatory and reimbursement risk.
−Removed: We believe our Simoa platforms are well-positioned to capture a significant share of these markets because of superior sensitivity, automated workflow capabilities, multiplexing and the ability to work with a broader range of sample types.
−Removed: By substantially lowering the limit of detection of protein biomarkers, our Simoa platforms hold significant potential to expand research into the diseases associated with the thousands of proteins that were previously undetectable, as well as into earlier detection of the proteins currently detectable by other technologies only after they have reached levels that reflect more advanced disease or injury.
−Removed: In addition, as pharmaceutical companies look for ways to more efficiently and effectively develop and obtain regulatory approval for drugs, use of biomarkers in clinical drug trials is becoming more prevalent.
−Removed: With Simoa’s sensitivity and its ability to detect many biomarkers in blood, plasma and other non-invasive samples that cannot be detected by many other technologies, we believe that we are uniquely positioned to take advantage of this opportunity.
−Removed: Using Simoa’s unprecedented sensitivity to measure previously undetectable levels of target biomarkers prior to and following administration of a drug, drug developers can non-invasively and objectively determine whether a drug candidate is having a desired impact on the target biomarker.
−Removed: According to estimates in the Third-Party Research Report, as we further expand our focus in these markets on other areas, such as immunology, oncology and other therapeutic areas, coupled with the growing adoption of decentralized clinical trials, the life science research/drug trial addressable market is expected to expand to as much as $12 billion.
−Removed: The diagnostic market represents a significant future commercial opportunity for our Simoa technology as well.
−Removed: We believe existing biomarker diagnostics, as well as invasive, expensive and inconvenient diagnostic methods, including spinal tap, diagnostic imaging and biopsy, can be improved by Simoa’s sensitivity to enable earlier detection of diseases and injuries.
−Removed: Simoa technology also has significant potential in the emerging field of companion diagnostics.
−Removed: Drug developers can use companion diagnostics to stratify patients and select only those patients for whom a drug is expected to be most effective and safe.
−Removed: In view of the COVID-19 pandemic, as an initial foray into the diagnostics market, in 2020 we began developing a SARS- CoV-2 semi-quantitative IgG assay and a SARS-CoV-2 antigen detection assay and prototyping a high-definition multiplex SARS-CoV-2 serology assay.
−Removed: We currently have EUAs for our Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test and our Simoa SARS-CoV-2 N Protein Antigen Test, each of which is run on our HD-X instrument.
−Removed: In addition, in 2021, our pTau-181 assay was granted Breakthrough Device Designation from the U.S.
−Removed: FDA as an aid in the diagnosis of Alzheimer’s disease.
−Removed: We believe this gives us an opportunity to further advance a potential Alzheimer’s disease diagnostic test either alone or with a partner.
−Removed: There has also been significant interest from third parties to use our technology to develop applications for the diagnostic market, such as our licensing and supply arrangement with Siemens Healthineers (Siemens) for access to our Nf-L antibodies, which will allow Siemens to begin developing blood-based Nf-L clinical tests for future commercialization, as well as our non-exclusive License Agreement with Abbott Laboratories, pursuant to which we granted Abbott a non-exclusive, worldwide, royalty-bearing license under our bead-based single molecule detection patents for IVD use.
−Removed: Precision Health Screening
−Removed: The ability of our Simoa platforms to detect and quantify normal physiological levels of low abundance proteins that are undetectable using conventional, analog immunoassay technologies could enable our technology to be used to monitor protein biomarker levels of seemingly healthy, asymptomatic people, and potentially to signal and provide earlier detection of the onset of disease.
−Removed: This has the potential to facilitate a paradigm shift in healthcare, from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention, enabling a “precision health” revolution.
−Removed: Simoa products sold or used in the diagnostics and precision health screening markets will be subject to regulation by the FDA or comparable international agencies, including requirements for regulatory clearance or approval of such products before they can be marketed.
−Removed: To date, other than our EUAs for our COVID assays, we have not received or applied for regulatory approvals for Simoa products.
−Removed: See “Risk Factors—Risks Related to Governmental Regulation and Diagnostic Product Reimbursement” and “—Government Regulation” for a more detailed discussion regarding the regulatory approvals that may be required.
+Added: To date, we have completed over 1,900 projects for more than 400 customers from all over the world using our Simoa platforms.
+Added: We have recently begun offering laboratory developed tests (LDTs) through the Accelerator Laboratory.
+Added: LDTs are diagnostic tests that are developed, validated and performed by a single laboratory.
+Added: In July 2022, we launched an LDT to quantitatively measure phospho-Tau 181 (pTau-181) in plasma as an aid in diagnostic evaluation of Alzheimer’s disease, and in January 2023, we launched an LDT to quantitatively measure neurofilament light chain (NfL) in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage.
+Added: In August 2019, we acquired UmanDiagnostics AB (Uman), a company located in Umeå, Sweden, that commercializes proprietary NfL antibodies and NfL ELISA kits.
+Added: Uman’s NfL antibodies are widely recognized by researchers and biopharmaceutical and diagnostics companies world-wide as the premier solution for the detection of NfL to advance the development of therapeutics and diagnostics for certain neurodegenerative conditions.
+Added: Since we commercially launched the first assay that could reliably measure NfL in blood using Uman’s antibodies and our Simoa technology in 2017, NfL has seen dramatic growth as a neurological biomarker.
+Added: The Uman acquisition secured the NfL antibody supply critical to our industry-leading ultrasensitive Simoa NfL assays and services and provides us with additional revenue via the sale of the NfL antibodies and NfL ELISA kits.
+Added: We sell our instruments, consumables and services to the life science, pharmaceutical and diagnostics industries through a direct sales force and support organizations in North America and Europe and through distributors or sales agents in select markets.
+Added: In addition, we sell Uman’s NfL antibodies and NfL ELISA kits directly and in conjunction with a distributor worldwide.
+Added: We have an extensive base of customers in world class academic and governmental
+Added: research institutions, as well as pharmaceutical, biotechnology and contract research companies, using our technology to gather information to better understand human health.
Our Competitive Strengths
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The sensitivity of our Simoa technology also allows researchers to gather biomarker information from smaller samples that can be collected less invasively than samples required by other assay technologies.
−Removed: We believe that sensitivity is so important that we have published an approach to increase the sensitivity of our Simoa technology – in some cases as much as 100-fold - and we intend to launch a beta program using this more sensitive technology in our Accelerator Laboratory by the end of 2022 .
● Technology platforms that leverage and improve upon industry standard ELISA technology.
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● Deep and expanding scientific validation and customer base.
−Removed: Our Simoa technology has been cited in approximately 1,600 publications to date, including JAMA Neurology and Nature , and is becoming a vital tool in cutting edge life sciences research.
−Removed: We have established relationships with key opinion leaders, and our growing base of over 1,120 customers includes some of the world’s leading academic and government research institutions as well as 22 of the 25 largest biopharmaceutical companies.
+Added: Our Simoa technology has been cited in over 2,000 publications to date, including JAMA Neurology and Nature , and is becoming a vital tool in cutting edge life sciences research.
+Added: We have established relationships with key opinion leaders, and our growing base of over 1,300 customers includes some of the world’s leading academic and government research institutions and many of the world’s largest biopharmaceutical companies.
● Leading position in market solidified by robust customization capabilities, assay design flexibility and automation of our HD-X instrument.
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This automation and speed provides customers high research and development productivity through greater throughput and lab efficiency.
−Removed: ● Highly attractive business model that leverages growing installed base of instruments.
−Removed: Our installed instrument base increased by 32% in 2021 to 708 instruments as of December 31, 2021.
+Added: ● Business model that leverages growing installed base of instruments.
+Added: Our installed instrument base increased to 876 instruments as of December 31, 2022.
The integration of our technology into our customers’ projects provides ongoing sales of assays and consumables, and as we continue to grow our installed instrument base, optimize workflows and expand our assay menu, we expect to increase our revenues derived from consumables.
−Removed: Our consumables and other product revenue increased by $27.7 million to $55.1 million in 2021 from $27.4 million in 2020 and $25.6 million in 2019.
−Removed: Consumables and other product revenue represented approximately 50% of our total revenue in 2021.
● Our highly experienced senior management team.
−Removed: We are led by a dedicated and highly experienced senior management team with significant industry experience and proven ability to develop novel solutions.
−Removed: Each of the members of our senior management has more than 20 years of relevant experience.
+Added: We are led by a dedicated and highly experienced senior management team with significant industry experience.
Our goal is to enable new research into biomarkers to allow greater insight into their role in human health in ways that have not been possible with any other current research and diagnostic technology.
−Removed: We believe this greater insight will facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention.
+Added: We believe this greater
+Added: insight will facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention.
Our strategy to achieve this includes:
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Our technology provides a unique bridge between understanding the human genotype and phenotype, which we believe addresses a large unmet need in life science research, translational medicine and diagnostic and drug development.
−Removed: ● Continue to drive adoption of our Simoa technology in the life science research/drug trial markets in the near-term, and the diagnostics and precision health screening markets in the long-term.
+Added: ● Continue to drive adoption of our Simoa technology in the life science research/pharma market.
We believe our Simoa technology has the potential to significantly expand the life science research market because of its unrivaled sensitivity, in particular by enabling researchers to perform studies on protein biomarkers that they were previously unable to perform.
−Removed: We also believe that our Simoa technology is uniquely positioned for use by pharmaceutical companies in drug trials as biomarkers are being increasingly used as an adjunct
−Removed: to help increase the potential of regulatory approval.
−Removed: We have focused on these markets because we believe there is reduced regulatory and reimbursement risk for us in these markets.
−Removed: However, we also believe Simoa technology has the capability to enable the development of a new category of less- invasive diagnostic tests and tools based on blood, serum, saliva and other fluids that could replace current invasive, expensive and inconvenient diagnostic methods, including spinal tap, diagnostic imaging and biopsy.
−Removed: We have had two EUAs approved for our COVID assays.
−Removed: In addition, in 2021 our pTau-181 assay was granted Breakthrough Device designation from the FDA as an aid in diagnostic evaluation of Alzheimer’s disease, and we are currently aiming to launch our first laboratory developed test in 2023.
−Removed: In the precision health screening market, we believe that Simoa technology has the potential to someday be used to monitor biomarker levels of seemingly healthy, asymptomatic people, and potentially to signal and provide earlier detection and monitoring of the onset of disease.
−Removed: ● Leverage the growing importance of Nf-L and other neurological biomarkers to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
−Removed: The importance of Nf-L and other neurological biomarkers, such as pTau-181 and pTau-217, has increased significantly in recent years, and our ultra-sensitive Simoa platforms have allowed research of neurological disorders, previously limited primarily to CSF, to expand significantly.
−Removed: To capitalize on the growing importance of Nf-L, in mid-2019, we acquired Uman and its proprietary Nf-L antibodies, which we believe are the best-in-class for highly sensitive and specific Nf-L detection in serum or plasma.
−Removed: In addition, other neuro biomarkers, such as pTau-217 and pTau-181, have shown increasing relevance in neurological research and drug development.
−Removed: In 2021, Lilly presented new data from its Phase 2 TRAILBLAZER-ALZ study of its Alzheimer’s disease drug candidate donanemab, which employed our ultra-sensitive Simoa technology to measure plasma pTau-217, using antibodies developed by Lilly.
+Added: We also believe that our Simoa technology is uniquely positioned for use by pharmaceutical companies in drug trials as biomarkers are being increasingly used as an adjunct to help increase the potential of regulatory approval.
+Added: We have focused initially on these markets because we believe there is reduced regulatory and reimbursement risk for us in these markets.
+Added: ● Expand our presence in the diagnostics market.
+Added: We believe Simoa technology has the capability to enable the development of a new category of less-invasive diagnostic tests and tools based on blood, serum, saliva and other fluids that could replace current invasive, expensive and inconvenient diagnostic methods, including spinal tap, diagnostic imaging and biopsy.
+Added: In July 2022, we launched an LDT to quantitatively measure pTau-181 in plasma as an aid in diagnostic evaluation of Alzheimer’s disease, and in January 2023, we launched an LDT to quantitatively measure neurofilament light chain (NfL) in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage.
+Added: ● Leverage the growing importance of neurological biomarkers to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
+Added: The importance of neurological biomarkers, such as NfL, pTau-181 and pTau-217, has increased significantly in recent years, and our ultra-sensitive Simoa platforms have allowed research of neurological disorders, previously limited primarily to cerebrospinal fluid (CSF), to expand significantly.
+Added: Neuro biomarkers, such as NfL, pTau-217 and pTau-181, have shown increasing relevance in neurological research and drug development.
+Added: In 2021, Eli Lilly and Company (Lilly) presented new data from its Phase 2 TRAILBLAZER-ALZ study of its Alzheimer’s disease drug candidate donanemab, which employed our ultra-sensitive Simoa technology to measure plasma pTau-217, using antibodies developed by Lilly.
Lilly reported a significant reduction in blood levels of phosphorylated Tau protein after treatment with donanemab, and that a reduction in plasma pTau-217 levels correlated with the slowing of cognitive decline.
−Removed: In addition, following the FDA approval of its Alzheimer’s disease drug ADUHELM™, Biogen conducted Simoa biomarker studies on Phase 3 EMERGE and ENGAGE trial samples, utilizing Simoa technology to measure plasma pTau-181.
−Removed: Preliminary data was reported that showed a dose-dependent reduction in plasma pTau-181 levels following treatment with ADUHELM, which correlated with decreases in amyloid PET and a slowing of cognitive decline across four independent assessment tools.
−Removed: We believe that the use of biomarkers in clinical trials for neurological conditions is becoming increasingly important.
+Added: In November 2022, Eisai Co., Ltd.
+Added: and Biogen Corporation presented results from the Phase 3 clinical trial (Clarity AD) of lecanemab, an investigational drug aimed at slowing the progression of cognitive decline caused by Alzheimer’s disease.
+Added: Target engagement and activity of the drug in downstream processes was explored with a panel of fluid biomarkers, including plasma pTau-181, glial fibrillary acidic protein (GFAP) and NfL using Quanterix’s ultrasensitive Simoa assay kits We believe that the use of biomarkers in clinical trials for neurological conditions is becoming increasingly important.
With Simoa’s sensitivity and its ability to detect many neurological biomarkers in blood and plasma that cannot be detected by many other technologies, we believe that we are uniquely positioned to take advantage of this opportunity.
−Removed: ● Grow into new markets organically with our customers and through strategic collaborations.
−Removed: Our customers have access to a large breadth of diverse markets, spanning research and clinical settings.
−Removed: As these customers continue to gain experience with our proprietary Simoa technology and further appreciate its potential, we believe moving into diagnostics and ultimately precision health is a natural extension of some of the work that our customers are doing today in the research market.
−Removed: For example, use of Simoa technology by pharmaceutical companies to measure biomarkers in clinical trials potentially could lead to a companion diagnostic, and ultimately a precision health test that could monitor and identify early disease.
−Removed: We believe this progression with our customers will help us move into new markets organically in a cost-effective manner, while also retaining significant upside.
−Removed: In addition, we have entered into, and will continue to explore, partnerships that will help us access these markets.
−Removed: For example, following our acquisition of Uman, we entered into a licensing and supply arrangement with Siemens Healthineers for access to Uman’s proprietary Nf-L antibodies, which will allow Siemens to begin developing blood-based Nf-L clinical tests for future commercialization.
−Removed: Additionally, in September 2020, we granted Abbott Laboratories a non-exclusive license under our bead-based single molecule detection patents for IVD use.
−Removed: ● Grow through strategic acquisitions.
−Removed: We intend to strategically acquire businesses and technologies to expand our operations and strengthen our market position.
−Removed: For example, in January 2018, we acquired Aushon and its proprietary sensitive planar array detection technology, which led to the development of our SP-X instrument.
−Removed: In mid-2019, we also acquired Uman, securing the Nf-L antibody supply critical to our industry leading ultrasensitive Simoa Nf-L assays and services and positioning us to capitalize on the
−Removed: growing significance of Nf-L as a neurological biomarker.
−Removed: We expect that acquisitions will continue to be an important part of our strategy to increase scale, and we intend to pursue acquisitions to expand product offerings, strengthen domestic or international distribution, add technologies, and/or provide access to complementary or strategic growth areas.
−Removed: ● Leverage the PPH ecosystem.
−Removed: Powering Precision Health (PPH) is a non-profit organization founded in 2016 by our Chief Executive Officer, Kevin Hrusovsky.
−Removed: PPH aims to gather many of the world’s top innovators, scientists, physicians, medical professionals, patient advocates, government officials, regulators and investors to discuss the critical issues and opportunities related to advancing precision medicine in key disease areas including neurology, oncology, cardiology, inflammation and infectious disease.
−Removed: Quanterix is uniquely positioned to leverage this PPH ecosystem to gather and synthesize key insights and information, to collaborate on important research, to deepen our credibility and expand our business opportunities in the proteomics space, and to raise awareness of the technological innovations, such as Simoa, that are powering the latest breakthroughs in medical research and precision health.
+Added: ● Expand further into indications beyond neurology.
+Added: Because the blood-brain barrier severely restricts the movement of proteins and other substances into blood circulation, we believe that our ultra-sensitive Simoa platforms are particularly well suited for neurology indications.
+Added: We also believe, however, that the ability of our Simoa technology to detect and quantify low abundance proteins is a distinct advantage in detecting disease earlier in other indications, including oncology, cardiology, infectious disease and inflammation, and there are nearly 700 scientific publications using our Simoa technologies in these non-neurology indications.
+Added: We intend to expand further into these markets, with a particular focus on oncology.
Industry Background
−Removed: We intend to pursue the application of our Simoa technology to the life science research/drug trial, diagnostics and precision health screening markets.
−Removed: Our initial commercial strategy targets the large and growing life science research/drug trial markets, and we believe that the diagnostic market and the precision health screening market represent significant future commercial opportunities for Simoa.
−Removed: According to estimates in the Third-Party Research Report, we believe the aggregate commercial opportunity across these markets has the potential to expand to over $100 billion.
+Added: We intend to pursue the application of our Simoa technology to the life science research/pharma and diagnostics markets.
+Added: Our initial commercial strategy has targeted the large and growing life science research/pharma markets, and we believe that the diagnostics market represents a significant commercial opportunity for Simoa.
+Added: Based on industry estimates, we believe the aggregate commercial opportunity across these markets is approximately $75 billion.
Proteins are versatile macromolecules and serve critical functions in nearly all biological processes.
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One of the core functions of genes, which are comprised of DNA, is to regulate protein production—which ones are produced, the volume of each, and for how long—influenced by both biological and environmental factors.
−Removed: These 20,000 genes help govern the expression of over 100,000 proteins, of which at least 10,000 are known to be secreted in blood, and fewer than 1,300 of which can be consistently detected in healthy individuals using conventional immunoassay technologies.
+Added: These 20,000 genes help govern the expression of over 100,000 proteins, of which 10,000 – 15,000 are estimated to be secreted in blood, the majority of which cannot be consistently detected in healthy individuals using conventional immunoassay technologies.
Accordingly, the study of much of the proteome has not been practical given the limited level of sensitivity of existing technologies.
−Removed: Currently, across our platforms, we commercialize assays that address approximately 154 protein biomarkers secreted or released in blood and CSF.
−Removed: While genomic research provides valuable information about the role of genes in health and disease, proteins are both more prevalent than nucleic acids and, we believe, more relevant to understand precisely the nuanced continuum between health and disease.
−Removed: Genes may indicate the risk of developing a certain disease later in life, but they are not able to account for the impact of environmental factors and lifestyle, such as diet and exercise, or provide insight into what is happening in a patient’s body in real time.
−Removed: For example, identical twins have the same genotype, but may develop different diseases over the course of their lifetime, largely due to environmental factors.
−Removed: Much like the sequencing of the human genome with the Human Genome Project and the development of both PCR and next generation sequencing technologies to detect nucleic acids, both of which accelerated biomedical genomic research, we believe the ability to study more of the proteome enabled by our more sensitive protein detection technology will have a profound impact on proteomic research.
−Removed: With our ultra-sensitive Simoa detection technology, researchers can assess the symptoms of disease or injury and compare them to the presence and levels of relevant proteins that are not detectable using conventional technologies, leading to a better understanding of how proteins individually and/or collectively impact and influence important biological processes and the health and well-being of
+Added: Much like the sequencing of the human genome with the Human Genome Project and the development of both polymerase chain reaction (PCR) and next generation sequencing technologies to detect nucleic acids, both of which accelerated biomedical genomic research, we believe the ability to study more of the proteome enabled by our more sensitive protein detection technology will have a profound impact on proteomic research.
+Added: With our ultra-sensitive Simoa detection technology, researchers can assess the symptoms of disease or injury and compare them to the presence and levels of relevant proteins that are not detectable using conventional technologies, leading to a better understanding of how proteins individually and/or collectively impact and influence important biological processes and the health and well-being of individuals.
We believe this research into understanding the individual characteristics and functioning of proteins will be central to earlier detection, monitoring, prognosis and, ultimately, prevention by providing researchers with the ability to assess the impact of particular proteins on the progress of disease and injury from the time of early onset of symptoms.
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A specific “detection” antibody is applied over the surface to bind to the antigen.
−Removed: This detection antibody is linked to an enzyme, and in the final step, a substance called an enzyme substrate is added, and the enzyme converts to colored or fluorescent product molecules, which are detected by a plate reader.
+Added: This detection antibody is linked to an enzyme, and in the final step, a substance called an enzyme substrate is added, and the
+Added: enzyme converts to colored or fluorescent product molecules, which are detected by a plate reader.
Sandwich ELISA is depicted in the graphic below:
Aside from ELISA, there are other technologies available for protein analysis today, such as Western blotting, mass spectrometry, chromatography, surface plasmon resonance, Raman-enhanced signal detection, immuno-PCR, and biobarcode assay.
−Removed: However, the proteins detectable by these conventional, analog immunoassay technologies represent a mere fraction of the at least 10,000 secreted proteins in circulation in human blood.
+Added: However, the proteins detectable by these conventional, analog immunoassay technologies represent a mere fraction of the 10,000-15,000 secreted proteins in circulation in human blood.
While a number of techniques have been used to attempt to increase sensitivity of detection, we believe all of these approaches have limitations, including:
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● narrow dynamic range (i.e., the range of concentration of proteins being detected), that may require sample dilution, diluting molecules and increasing sample volume requiring additional enzymes to reach detection limit;
−Removed: ● low detection limit of readers restrict sensitivity and ability to detect low abundance proteins, particularly when proteins are at normal physiological levels;
+Added: ● low detection limit of readers restricts sensitivity and ability to detect low abundance proteins, particularly when proteins are at normal physiological levels;
● limited success in increasing sensitivity of detection due to procedural complexity and length.
29 unchanged sentences
The entire array is then imaged using ultrasensitive digital imaging, and the sealed wells that contain beads associated with captured and enzyme labeled protein molecules are identified.
−Removed: Our Simoa bead-based technology offers unprecedented protein detection sensitivity and enables detection of low abundance and previously undetectable biomarkers.
−Removed: This sensitivity allows researchers to measure critical protein biomarkers at earlier stages in the progression of a disease or injury, which we believe will enable the development of novel therapies and diagnostics and facilitate a paradigm shift in healthcare from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention.
The ability to multiplex, or simultaneously measure multiple proteins (or other biomarkers) in a single assay, can be important to researchers to maximize the biological information from a sample and to develop more specific diagnostic tests.
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Our Simoa platforms maintain single plex precision, while competitive platforms lose sensitivity when multiplexing is used.
−Removed: Multiplexing is
−Removed: achieved with our Simoa bead- based technology by using beads labeled with different fluorescent dyes specific to the biomarker being analyzed.
+Added: Multiplexing is achieved with our Simoa bead- based technology by using beads labeled with different fluorescent dyes specific to the biomarker being analyzed.
After the assay is run, the array of microwells is imaged across the wavelengths of the different labeled beads.
The results are measured for each protein captured by each of the different beads.
−Removed: In 2017, we commercially launched a Simoa neurology 4-plex assay (Nf-L, tau, GFAP and UCH- L1) for the study of neurodegenerative conditions and traumatic brain injury.
−Removed: In 2020, we introduced a Simoa 4-plex assay (Aβ40, Aβ42, GFAP, Nf-L) designed to measure key biomarkers of Alzheimer’s disease and related disorders.
−Removed: Whereas other assay technologies require CSF to detect all four of these markers, or are limited to only single-plex measurement in serum and plasma, due to Simoa’s sensitivity, this is the only assay that can detect all of these biomarkers directly from serum and plasma samples in a multiplex assay format.
+Added: In 2017, we commercially launched a Simoa neurology 4-plex assay (NfL, tau, GFAP and UCH- L1) for the study of neurodegenerative conditions and traumatic brain injury.
+Added: In 2020, we introduced a Simoa 4-plex assay (Aβ40, Aβ42, GFAP, NfL) designed to measure key biomarkers of Alzheimer’s disease and related disorders.
+Added: Whereas other assay technologies require CSF to detect all four of these markers, or are limited to only single-plex measurement in serum and plasma, due to Simoa’s sensitivity, we believe this is the only assay that can detect all of these biomarkers directly from serum and plasma samples in a multiplex assay format.
This is a significant advantage in terms of ease of use, patient comfort, speed and cost-effectiveness.
−Removed: While we have demonstrated the ability to identify and differentiate up to 35 different bead subpopulations on the HD-X, which is a prerequisite to our ability to develop assays with the capacity to detect an equivalent number of proteins in a single sample, we believe that the ability to multiplex above a 6-plex and maintain single-plex sensitivity and precision is currently limited using bead-based technology due to constraints in the number of bead- containing wells for each plex that are imaged on the Simoa disk.
+Added: While we have demonstrated the ability to identify and differentiate up to 35 different bead subpopulations on the HD-X, which is a prerequisite to our ability to develop assays with the capacity to detect an equivalent number of proteins in a single sample, we believe that the ability to multiplex at high levels and maintain single-plex sensitivity and precision is currently limited using bead-based technology due to constraints in the number of bead- containing wells for each plex that are imaged on the Simoa disk.
However, our bead-based assay technology was used by researchers to demonstrate a novel workflow to expand multiplexing through a process of sequential incubation steps.
−Removed: We plan to explore this and other methods to potentially expand the multiplexing capabilities of our Simoa assay technology to enable plexing of 10-20 plex over the next two years.
+Added: We plan to explore this and other methods to potentially expand the multiplexing capabilities of our Simoa assay technology to enable plexing of 10-20 plex over the next several years.
Simoa Planar Array Technology
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The low background of the plate surface and the high-sensitivity of the camera enable detection of very low levels of light with a high dynamic range.
−Removed: The SP-X imaging software utilizes algorithms to optimize exposure time and combine multiple images in the image analysis.
+Added: The imaging software utilizes algorithms to optimize exposure time
+Added: and combine multiple images in the image analysis.
Protein concentrations are determined by comparing the intensity of microspots to known analytical standards.
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Our Market Opportunities
−Removed: Our commercial strategy is to pursue the application of our Simoa technology to the life science research/drug trial, diagnostics and precision health screening markets.
−Removed: Life Science Research/Drug Trial Markets
−Removed: Our initial target market is the large and growing life science research and drug trial markets, which we sometimes refer to collectively as the translational market.
+Added: Our commercial strategy is to pursue the application of our Simoa technology to the life science research/pharma and diagnostics markets.
+Added: Life Science Research/Pharma Markets
+Added: We have initially targeted the large and growing life science research and pharma markets.
We have chosen these markets to target initially because of the reduced regulatory and reimbursement risk.
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In addition, as pharmaceutical companies look for ways to more efficiently and effectively develop and obtain regulatory approval for drugs, use of biomarkers in clinical drug trials is becoming more prevalent.
−Removed: With Simoa’s sensitivity and its ability to detect many biomarkers in blood, plasma and other non-invasive samples that cannot be detected by many other technologies, we believe that we are uniquely positioned to take advantage of this opportunity.
+Added: Biomarkers are increasingly being used as clinical endpoints in clinical trials.
+Added: Drug developers can also use diagnostics to stratify patients and select only those patients for whom a drug is expected to be most effective and safe.
Using Simoa’s unprecedented sensitivity to measure previously undetectable levels of target biomarkers prior to and following administration of a drug, drug developers can non-invasively and objectively determine whether a drug candidate is having a desired impact on the target biomarker.
In addition, researchers can also use Simoa to monitor a drug candidate’s unwanted effect on “off-target” biomarkers and predict side effects, addressing the significant issue of drug toxicity, which is a leading cause of death in the United States.
−Removed: According to estimates in the Third-Party Research Report, as we further expand our life science research focus in other areas of immunology, oncology and other therapeutic areas, coupled with growing adoption of decentralized clinical trials, the life science research/drug trial addressable market is expected to expand to as much as $12 billion.
−Removed: The diagnostic market represents a significant future commercial opportunity for our Simoa technology as well.
+Added: With Simoa’s sensitivity and its ability to detect many biomarkers in blood, plasma and other non-invasive samples that cannot be detected by many other technologies, we believe that we are uniquely positioned to take advantage of this opportunity.
+Added: Based on industry estimates, we believe the proteomics life science research/pharma total addressable market is approximately $20 billion.
+Added: The diagnostic market represents a significant commercial opportunity for our Simoa technology as well.
We believe existing biomarker diagnostics can be improved by Simoa’s sensitivity to enable earlier detection of diseases and injuries, and that new diagnostics may be developed using protein biomarkers that are not detectable using conventional, analog immunoassay technologies but are detectable using Simoa technology.
−Removed: We also believe that the ultra-sensitive protein detection provided by our Simoa platforms can enable the development of a new category of non-invasive diagnostic tests and tools based on blood, serum and other fluids that have the potential to replace current more invasive, expensive and inconvenient diagnostic methods, including spinal tap, diagnostic imaging and biopsy.
−Removed: Simoa technology also has significant potential in the emerging field of companion diagnostics.
−Removed: A companion diagnostic test is a biomarker test that is specifically linked to a therapeutic drug that can help predict how a patient will respond to the drug.
−Removed: Drug developers can use companion diagnostics to stratify patients and select only those patients for whom a drug is expected to be most effective and safe.
−Removed: Companion diagnostics have demonstrated the ability to both improve the probability of approval and accelerate approval of new drugs.
−Removed: Not only could Simoa be used to develop companion diagnostics to stratify patients in clinical trials and for treatment, but Simoa’s sensitivity can also enable the development of companion diagnostics based on protein biomarkers that can actively and regularly monitor whether an approved drug is having the desired biological effect.
+Added: We also believe that the ultra-sensitive protein detection provided by our Simoa platforms can enable the development of a new category of non-invasive
+Added: diagnostic tests and tools based on blood, serum and other fluids that have the potential to replace current more invasive, expensive and inconvenient diagnostic methods, including spinal tap, diagnostic imaging and biopsy.
+Added: Simoa technology also has significant potential in the emerging field of screening and diagnostics.
+Added: A screen, aid to diagnostic, or diagnostic test is a biomarker test that is specifically linked to a therapeutic drug that can help predict how a patient will respond to the drug.
+Added: Drug developers can use these tests to stratify patients and select only those patients for whom a drug is expected to be most effective and safe.
+Added: Such tests have demonstrated the ability to both improve the probability of approval and accelerate approval of new drugs.
+Added: Not only could Simoa be used to develop tests to stratify patients in clinical trials and for treatment, but Simoa’s sensitivity can also enable the development of tests based on protein biomarkers that can actively and regularly monitor whether an approved drug is having the desired biological effect.
This would quickly and efficiently enable doctors to adjust the course of treatment as appropriate by increasing or decreasing dosages or even switching therapies.
−Removed: In view of the COVID-19 pandemic, as an initial foray into the diagnostics market, in 2020 we began developing a SARS- CoV-2 semi-quantitative IgG assay and a SARS-CoV-2 antigen detection assay and prototyping a high-definition multiplex SARS-CoV-2 serology assay.
−Removed: In December 2020, the FDA issued an EUA for our Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test, and in January 2021, the FDA issued an EUA for our Simoa SARS-CoV-2 N Protein Antigen Test, each of which is run on our HD-X instrument.
−Removed: In September 2021, the FDA expanded the EUA for our Simoa SARS-CoV-2 N Protein Antigen Test to include testing with nasal swabs and saliva and for asymptomatic serial testing with nasal swab samples.
−Removed: We are exploring extending the test to home-based sample collection and pooling to enable larger scale testing.
−Removed: In 2021, our pTau-181 assay was granted Breakthrough Device designation from the FDA as an aid in the diagnosis of Alzheimer’s disease.
−Removed: We believe this gives us an opportunity to further advance a potential Alzheimer’s disease diagnostic test either alone or with a partner.
+Added: The ability of our Simoa platforms to detect and quantify normal physiological levels of low abundance proteins that are undetectable using conventional, analog immunoassay technologies could enable our technology to be used to monitor protein biomarker levels of seemingly healthy, asymptomatic people, and potentially to signal and provide earlier detection of the onset of disease.
+Added: This has the potential to facilitate a paradigm shift in healthcare, from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention.
+Added: We recently launched our first diagnostic LDTs in our Accelerator Laboratory.
+Added: In July 2022, we launched an LDT to quantitatively measure pTau-181 in plasma as an aid in diagnostic evaluation of Alzheimer’s disease, and in January 2023, we launched an LDT to quantitatively measure NfL in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage.
There has also been significant interest from third parties to use our technology to develop applications for the diagnostic market.
−Removed: Following our acquisition of Uman, we entered into a licensing and supply arrangement with Siemens Healthineers for access to Uman’s proprietary Nf-L antibodies, which will allow Siemens to begin developing blood-based Nf-L clinical tests for future commercialization.
+Added: Following our acquisition of Uman, we entered into a licensing and supply arrangement with Siemens Healthineers for access to Uman’s proprietary NfL antibodies, which will allow Siemens to begin developing blood-based NfL clinical diagnostic tests for future commercialization.
Additionally, in September 2020, we entered into a non-exclusive License Agreement with Abbott Laboratories, pursuant to which we granted Abbott a non-exclusive, worldwide, royalty-bearing license under our bead-based single molecule detection patents for IVD use.
−Removed: Precision Health Screening
−Removed: The ability of our Simoa platforms to detect and quantify normal physiological levels of low abundance proteins that are undetectable using conventional, analog immunoassay technologies could enable our technology to be
−Removed: used to monitor protein biomarker levels of seemingly healthy, asymptomatic people, and potentially to signal and provide earlier detection of the onset of disease.
−Removed: This has the potential to facilitate a paradigm shift in healthcare, from an emphasis on treatment to a focus on earlier detection, monitoring, prognosis and, ultimately, prevention, enabling a “precision health” revolution.
−Removed: We believe there is the potential for a number of neurological, cardiovascular, oncologic and other protein biomarkers associated with disease to be measured with a simple blood draw on a regular, ongoing basis as part of a patient’s routine health screening, and for those results to be compared periodically with baseline measurements to predict or detect the early onset of disease, prior to the appearance of symptoms.
+Added: Based on industry estimates, we believe the proteomics diagnostic total addressable market is approximately $55 billion.
+Added: See “Government Regulation” and “Risk Factors—Risks Related to Governmental Regulation and Diagnostic Product Reimbursement” for a discussion regarding the regulatory approvals that may be required for use of our products for diagnostic purposes, and related risks.
Our Key Focus Areas
−Removed: We have focused the application of our Simoa technology on areas of high growth and high unmet need and where existing platforms have significant shortcomings that our technology addresses.
−Removed: In particular, we have focused on neurology and oncology, as well as COVID, cardiology, infectious disease and inflammation.
−Removed: We believe that the ability of our Simoa technology to detect neurological biomarkers in blood at ultra-low levels, which have traditionally only been detectable in cerebrospinal fluid (CSF), has the potential to rapidly advance neurology research and drug development, and transform the way brain diseases and injuries are diagnosed and treated.
−Removed: To our knowledge, the brain is the only organ in the body for which there is not currently a blood-based diagnostic test.
+Added: We have focused the application of our Simoa technology on areas of high growth and high unmet need and where existing platforms have significant shortcomings that our technology addresses, including neurology and oncology, as well as cardiology, infectious disease and inflammation.
+Added: We believe that the ability of our Simoa technology to detect neurological biomarkers in blood at ultra-low levels, which have traditionally only been detectable in CSF, has the potential to rapidly advance neurology research and drug development, and transform the way brain diseases and injuries are diagnosed and treated.
+Added: Prior to the launch of our pTau-181 LDT for clinical use in July 2022, the brain was the only organ in the body for which there was not a blood-based diagnostic test.
The challenge with developing blood-based tests for the brain is that the blood-brain barrier, which is formed by endothelial cells lining the cerebral microvasculature, is very tight and severely restricts the movement of proteins and other substances between these endothelial cells and into blood circulation.
−Removed: Accordingly, diagnosis of brain disease and injury has traditionally required either an MRI scan of the brain or a spinal tap to collect CSF, both of which are costly and highly invasive for the patient.
+Added: Accordingly, diagnosis of brain disease and injury has traditionally required either brain imaging or a spinal tap to collect CSF, both of which are costly
+Added: and highly invasive for the patient.
The sensitivity of the Simoa technology has enabled researchers to discover that extremely small amounts of critical neural biomarkers diffuse through the blood-brain barrier and are released into the blood during injury and in connection with many neurodegenerative brain diseases.
−Removed: However, the concentrations of many these neural biomarkers in the blood are so low that they are undetectable by conventional, analog immunoassay technologies.
−Removed: To date, there have been over 1,000 neurology-related scientific publications using our Simoa technologies, and we believe that ultra- sensitive digital detection of neural related biomarkers in the blood is becoming an essential research and development tool for an increasing range of neurological disorders, including Alzheimer’s disease, multiple sclerosis, dementia, Parkinson’s disease, and traumatic brain injury, or TBI.
+Added: However, the concentrations of many these neural biomarkers in the blood can be so low that they are difficult to detect by conventional, analog immunoassay technologies.
+Added: To date, there have been over 1,400 neurology-related scientific publications using our Simoa technologies, and we believe that ultra-sensitive digital detection of neural-related biomarkers in the blood is becoming an essential research and development tool for an increasing range of neurological disorders, including Alzheimer’s disease, multiple sclerosis, frontotemporal dementia, Parkinson’s disease, and traumatic brain injury (TBI).
The goal of this research is to eventually develop accurate diagnostic tools, predictive health screens and, ultimately, more effective treatments.
−Removed: The importance of Nf-L and other neurological biomarkers, such as pTau-181 and pTau-217, has increased significantly in recent years.
+Added: The importance of neurological biomarkers, such as NfL, pTau-181, pTau-217, GFAP and A b 42/40, has increased dramatically in recent years.
In addition, biomarkers are being increasingly used as an adjunct by pharmaceutical companies in clinical trials to help increase the potential for regulatory approval, particularly in neurological indications.
With Simoa’s sensitivity and its ability to detect many neurological biomarkers in blood and plasma that cannot be detected by many other technologies, we believe that we are uniquely positioned to take advantage of this opportunity, in particular with respect to Alzheimer’s disease and multiple sclerosis.
+Added: Dementia/Alzheimer’s Disease
Dementia is a collective name for brain syndromes that affect memory, thinking, behavior and emotion.
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Alzheimer’s disease is a progressive neurodegenerative disorder that affects cognition, function and behavior and is the most common cause of dementia.
+Added: In November 2022 at the 15 th Clinical Trials on Alzheimer’s Disease (CTAD) conference, Eisai Co., Ltd.
+Added: and Biogen Corporation presented results from the Phase 3 clinical trial (Clarity AD) of lecanemab, an investigational drug aimed at slowing the progression of cognitive decline caused by Alzheimer’s disease.
+Added: Target engagement and activity of the drug in downstream processes was explored with a panel of fluid biomarkers, including plasma pTau-181, GFAP and NfL, using Quanterix’s ultrasensitive Simoa assay kits.
+Added: In January 2023, the FDA approved lecanemab for the treatment of patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
In 2021, Lilly presented new data from its Phase 2 TRAILBLAZER-ALZ study of its Alzheimer’s disease drug candidate donanemab, which employed our ultra-sensitive Simoa technology to measure plasma pTau-217, using antibodies developed by Lilly.
−Removed: Lilly reported a significant reduction in blood levels of phosphorylated Tau protein after treatment with donanemab, and that a reduction in plasma pTau-217 levels correlated with the slowing of cognitive
+Added: Lilly reported a significant reduction in blood levels of phosphorylated Tau protein after treatment with donanemab, and that a reduction in plasma pTau-217 levels correlated with the slowing of cognitive decline.
In addition, following the FDA approval of its Alzheimer’s disease drug ADUHELM™, Biogen conducted Simoa biomarker studies on Phase 3 EMERGE and ENGAGE trial samples, utilizing Simoa technology to measure plasma pTau-181.
Preliminary data was reported that showed a dose-dependent reduction in plasma pTau-181 levels following treatment with ADUHELM, which correlated with decreases in amyloid PET and a slowing of cognitive decline across four independent assessment tools.
−Removed: These results highlight the potential role for emerging biomarker measurements in the detection of Alzheimer’s disease pathology even earlier in the disease continuum, when patients are asymptomatic and not yet exhibiting brain pathology in PET imaging studies.
−Removed: In 2017, researchers using Simoa technology published a paper in JAMA Neurology demonstrating that a simple blood test for Nf-L exhibited the same level of diagnostic accuracy for diagnosing Alzheimer’s disease as currently established CSF biomarkers.
−Removed: The study was a major study of almost 600 patients from the Alzheimer’s Disease Neuroimaging Initiative.
−Removed: The graph below depicts the diagnostic accuracy of plasma Simoa Nf-L measurements compared with traditional CSF biomarkers.
−Removed: The diagnostic accuracy of the plasma Simoa Nf-L results approached 90%, in line with the CSF biomarkers on the same patients.
−Removed: Diagnostic Accuracy
−Removed: In addition, Simoa plasma Nf-L values were associated with cognitive deficits and neuroimaging hallmarks of Alzheimer’s disease at baseline and during follow-up.
−Removed: High plasma Nf-L correlated with poor cognition and Alzheimer’s disease-related brain atrophy and with brain hypometabolism (lower neural energy).
−Removed: These data suggest a simple Simoa blood test for Nf-L may have clinical utility as a noninvasive biomarker in Alzheimer’s disease.
In October 2021, the FDA granted our Simoa pTau-181 blood test Breakthrough Device designation as an aid in diagnostic evaluation of Alzheimer’s disease.
−Removed: We believe this gives us an opportunity to further advance a potential Alzheimer’s disease diagnostic test either alone or with a partner.
The FDA’s Breakthrough Device designation is granted to products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need.
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Proposed indications under the Breakthrough Device designation include use of the test results in adult patients, aged 50 years and over, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline as an aid in diagnostic evaluation for Alzheimer’s disease.
+Added: In March 2022, we were awarded funding of $2.3 million by the Alzheimer’s Drug Discovery Foundation (ADDF) in support of a proposal “Clinical Implementation of Blood-Based Biomarkers for Alzheimer’s Disease:
+Added: Clinical Validation, IVD Product Development, and Market Development.” ADDF is a philanthropic foundation which
+Added: aims to accelerate Alzheimer’s drug and diagnostics development.
+Added: The project is aimed at clinically validating a multi-biomarker blood test for detection of Alzheimer’s disease in a large prospective trial that includes both primary care and specialist memory clinical settings.
+Added: The multi-biomarker approach is based on studies that have shown that combining the signals from multiple biomarkers relevant to Alzheimer’s pathophysiology provides greater diagnostic accuracy than any single biomarker alone.
+Added: The Simoa pTau-181 assay will be part of the multi-biomarker test, as well as our GFAP, NfL, A b 42, and A b 40 assays.
+Added: The latter four assays are multiplexed into a single test that measures all biomarkers simultaneously.
+Added: Thus, this validation study will serve to validate pTau-181 as a standalone test and will also leverage Simoa’s multiplexing capability to combine additional biomarkers for even greater accuracy.
+Added: In addition to the ADDF clinical validation program, we are nearing completion of a second prospective clinical trial (BioHermes) in partnership with the Global Alzheimer’s Platform Foundation (GAPF).
+Added: GAPF is a non-profit organization dedicated to speeding the delivery of innovative therapies to Alzheimer’s patients by reducing the time and cost of Alzheimer’s disease clinical trials.
+Added: The BioHermes trial is being conducted across 17 clinical sites in the United States and is examining blood test accuracy across 1,000 cognitively normal and mildly impaired Alzheimer’s patients in comparison with amyloid PET scan.
+Added: This study is expected to support a regulatory filing for FDA clearance of our pTau-181 test pursuant to the Breakthrough Device designation.
+Added: Multiple Sclerosis
Multiple sclerosis is a chronic disease affecting the central nervous system (the brain and spinal cord).
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According to the National MS Society, more than 2.3 million people have a diagnosis of multiple sclerosis globally.
−Removed: alone, the National MS Society recently completed a prevalence study estimating nearly 1 million people over the age of 18 live with a diagnosis of MS.
−Removed: Evidence of the potential clinical utility of Nf-L as a biomarker in multiple sclerosis is progressing rapidly, and Simoa’s role in that progression has been significant.
+Added: alone, the National MS Society recently completed a prevalence study estimating nearly 1,000,000 people over the age of 18 live with a diagnosis of multiple sclerosis.
+Added: Evidence of the potential clinical utility of NfL as a biomarker in multiple sclerosis is progressing rapidly, and Simoa’s role in that progression has been foundational.
+Added: The Simoa NfL assay pioneered measurement of NfL in blood, and in the past five years, the Simoa NfL assay has been used in hundreds of published studies.
In 2022, Simoa technology supported 35 scientific presentations at the 38 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), the world’s largest meeting dedicated to advancing research for multiple sclerosis .
−Removed: In 2020, Simoa supported 42 presentations at ECTRIMS, and a t ECTRIMS in 2019, there were nearly 50 presentations in which our Simoa Nf-L assay was used.
+Added: In 2021, Simoa technology supported 31 scientific presentations at ECTRIMS.
+Added: In 2020, Simoa supported 42 presentations at ECTRIMS.
+Added: A t ECTRIMS in 2019, there were nearly 50 presentations in which our Simoa NfL assay was used.
As an example, in one 2019 presentation, Novartis presented positive data from its Phase III ASCLEPIOS I and II studies of its multiple sclerosis drug candidate, ofatumumab.
−Removed: One of the secondary endpoints included serum levels of Nf-L as measured using our Simoa Nf-L assay.
−Removed: Novartis presented data that showed that, starting at three months after initiation of ofatumumab treatment, and then at 12 and 24 months timepoints, patients given ofatumumab had significantly lower blood levels of Nf-L, compared to those in the comparator arm of teriflunomide treated patients.
+Added: One of the secondary endpoints included serum levels of NfL as measured using our Simoa NfL assay.
+Added: Novartis presented data that showed that, starting at three months after initiation of ofatumumab treatment, and then at 12 and 24 months timepoints, patients given ofatumumab had significantly lower blood levels of NfL, compared to those in the comparator arm of teriflunomide treated patients.
In another ECTRIMS presentation in 2019, Roche presented retrospective data from its Phase III OPERA I, OPERA II and ORATORIO trials of its approved multiple sclerosis drug OCREVUS (ocrelizumab).
−Removed: In the data presented at ECTRIMS, it was shown that treatment with OCREVUS lowered blood Nf-L levels and increased proportion of patients reaching healthy donor range for Nf-L in both relapsing multiple sclerosis and primary progressive multiple sclerosis.
−Removed: Roche believes that this data helps advance the understanding of Nf-L as a potential biomarker of disease activity and for treatment monitoring, and may provide insight into the neuroprotective effects of the drug.
+Added: In the data presented at ECTRIMS, it was shown that treatment with OCREVUS lowered blood NfL levels and increased the proportion of patients reaching healthy donor range for NfL in both relapsing multiple sclerosis and primary progressive multiple sclerosis.
+Added: Roche believes that this data helps advance the understanding of NfL as a potential biomarker of disease activity and for treatment monitoring and may provide insight into the neuroprotective effects of the drug.
In an article published by Bjornevik, et al.
−Removed: in JAMA Neurology in September 2019, researchers presented data that showed that levels of serum Nf-L, as measured by the Simoa Nf-L assay, were increased six years before the clinical onset of multiple sclerosis.
−Removed: The researchers concluded that these data indicate that multiple sclerosis may have a prodromal phase lasting several years and that neuroaxonal damage occurs during this phase, emphasizing the importance of early diagnosis and treatment.
−Removed: In a study published in Science in January 2022, researchers leveraged Simoa’s ability to detect the Nf-L at ultra-low levels to show that Epstein-Barr virus (EBV) increases susceptibility toward developing multiple sclerosis.
+Added: in JAMA Neurology in September 2019, researchers presented data that showed that levels of serum NfL, as measured by the Simoa NfL assay, were increased six years before the clinical onset of multiple sclerosis.
+Added: The researchers concluded that these data indicate that multiple sclerosis may have a
+Added: prodromal phase lasting several years and that neuroaxonal damage occurs during this phase, emphasizing the importance of early diagnosis and treatment.
+Added: In a study published in Science in January 2022, researchers leveraged Simoa’s ability to detect the NfL at ultra-low levels to show that Epstein-Barr virus (EBV) increases susceptibility toward developing multiple sclerosis.
Researchers of the study tested the hypothesis that multiple sclerosis is caused by EBV in a cohort comprising more than 10 million young adults on active duty in the U.S.
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Risk of multiple sclerosis increased 32-fold after infection with EBV, but was not increased after infection with other viruses, including the similarly transmitted cytomegalovirus.
−Removed: Serum levels of Nf-L, a biomarker of neuroaxonal degeneration, increased only after EBV seroconversion, suggesting that EBV played a role in nerve cell damage.
+Added: Serum levels of NfL, a biomarker of neuroaxonal degeneration, increased only after EBV seroconversion, suggesting that EBV played a role in nerve cell damage.
+Added: In April 2022, the FDA granted our Simoa NfL plasma test Breakthrough Device designation as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting multiple sclerosis (RRMS).
+Added: The test has shown promise to be used in conjunction with clinical, imaging and laboratory findings as an aid in identifying RRMS patients who are at lower or higher risk for relapse within four years.
+Added: We believe this prognostic information could be clinically useful in tailoring the therapeutic approach to more effectively treat the disease.
+Added: Traumatic Brain Injury (TBI)
TBIs lead to approximately five million individuals visiting emergency rooms per year in the United States alone, often with broad and inconclusive diagnosis.
Current methods of TBI diagnosis involve CT scans that fail to diagnose approximately 90% of mild TBI.
−Removed: Simoa technology has demonstrated the sensitivity to identify relevant neurological biomarkers, such as Nf-L, tau, GFAP and UCH-L1, to more adequately address diagnosis of TBIs and overall brain health.
+Added: Simoa technology has demonstrated the sensitivity to identify relevant neurological biomarkers, such as NfL, tau, GFAP and UCH-L1, to more adequately address diagnosis of TBIs and overall brain health.
Leading researchers in neurology have used Simoa technology to study biomarkers in the blood of athletes after concussion in many high-impact sports.
Simoa can measure critical neural biomarkers in blood that correlate repeated head trauma from both concussions and subconcussive events with poor patient outcomes, including the potential development of Chronic Traumatic Encephalopathy (CTE), which currently can only be diagnosed after death via a brain autopsy.
−Removed: A recent publication by a National Institute of Health researcher indicates that measuring tau in the blood with Simoa may help identify concussed individuals requiring additional rest before they can safely return to play.
−Removed: Eventually, we believe it may be possible to develop a mobile screen enabling clinicians to quickly and accurately determine whether it is safe for concussed athletes to return to play.
−Removed: In 2016, Fast Company named Quanterix one of the “World’s Most Innovative Companies” for our work in concussion detection.
−Removed: We also were awarded two competitive grants from the NFL-GE Head Health Challenge to advance this work in the detection and quantification of mild TBI.
+Added: A publication by a National Institute of Health researcher indicates that measuring tau in the blood with Simoa may help identify concussed individuals requiring additional rest before they can safely return to play.
Our ultra-sensitive Simoa technology has the potential to detect increased levels of oncology biomarkers during the very early stages in disease development.
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Additionally, Simoa technology has shown early promise as a liquid biopsy alternative to more invasive diagnostic procedures.
−Removed: Simoa technology was used in an unpublished scientific study that indicates it may be possible to eventually replace routine mammograms with a very sensitive, more accurate, low cost, non-invasive blood test.
−Removed: In this retrospective study, researchers found that Simoa assays resulted in significantly fewer false positives and false negatives than mammography.
−Removed: Inaccurate mammography can result in unnecessary stress, additional health care costs from follow up diagnostic mammograms, unnecessary biopsies and increased lifetime exposure to radiation.
−Removed: Researchers are also developing ultrasensitive assays for lung and pancreatic cancer biomarkers using Simoa technology, potentially replacing the need for imaging and biopsy.
−Removed: We believe our Simoa technology has the potential to lead to rapid, cost effective, accurate blood-based health screens, further enabling the liquid biopsy market.
Cancer immunotherapy is a promising new area that is significantly affecting cancer remission rates.
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One technical challenge facing the immuno-oncology drug development process has been the availability of immunoassays with sufficient sensitivity to measure immunomodulatory biomarkers directly in serum and plasma.
−Removed: We have developed a set of over 100 tumor biomarker and immune modulation assays (cytokines and chemokines) that can be used to monitor tumor proliferation and host immune response.
+Added: We have developed a number of tumor biomarker and immune modulation assays (cytokines and chemokines) that can be used to monitor tumor proliferation and host immune response.
In particular key immune regulatory cells (T-regs, dendritic cells, macrophages) secrete very low amounts of the protein Interferon gamma (IFN-gamma) and these levels cannot be reliably measured in serum and plasma using conventional, immunoassay technology, however they can be tracked with our Simoa IFN-gamma assay.
−Removed: Additionally, we have developed an ultra-sensitive assay for IL-6, which is one of the cytokines commonly measured for monitoring cytokine release syndrome as an adverse effect in immunotherapies.
+Added: Additionally, we have developed an ultra-sensitive assay for IL-6, which
+Added: is one of the cytokines commonly measured for monitoring cytokine release syndrome as an adverse effect in immunotherapies.
Several studies have shown that our ultrasensitive assays can be valuable tools for monitoring immuno-oncology drugs and protocols.
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This has the potential to be a powerful prognostic tool, and allowing adjuvant radiation treatment to be targeted only to the men who actually would benefit.
−Removed: In view of the COVID-19 pandemic, in 2020 we determined that our cytokine assay technology could provide researchers with important and differentiated tools to study disease progression, cytokine release syndrome, and patient-treatment response in the fight against COVID-19, and began developing a SARS-CoV-2 semi-quantitative IgG assay and a SARS-CoV-2 antigen detection assay and prototyping a high-definition multiplex SARS-CoV-2 serology assay.
−Removed: In December 2020, the FDA issued an EUA for our Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test that is run on our HD-X instrument.
−Removed: This test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein.
−Removed: The spike protein contains multiple subunits which together mediate entry of the virus into human cells, and for this reason, many candidate and authorized COVID-19 vaccines are designed to elicit an antibody response to the spike protein.
−Removed: Accordingly, we believe that this test may be useful for measuring the antibody response to vaccine therapy.
−Removed: The assay may also be used for measurement of IgG antibodies in patients suspected of previous infection or recent SARS-CoV-2 exposure.
−Removed: The test provides a numerical result representing the concentration of antibodies from 0.21 to 250 mg/mL.
−Removed: In clinical studies, the test demonstrated a 100% positive percent agreement (sensitivity) and 99.2% negative percent agreement (specificity) 15 or more days following a positive PCR test.
−Removed: In January 2021, the FDA issued an EUA for our Simoa SARS-CoV-2 N Protein Antigen Test that is also run on our HD-X instrument.
−Removed: This test detects the presence of the SARS-CoV-2 virus nucleocapsid protein (or N protein) which is known to be elevated in respiratory fluids during the initial acute phase of the infection.
−Removed: We believe that direct detection of antigen proteins from the virus may be a more meaningful measure of infection status than detection of RNA by rRT-PCR because genetic material can linger even after the virus has left the body, resulting in increased risk of false positives.
−Removed: In clinical studies, this test demonstrated a sensitivity of 97.7% and specificity of 100% up to 14 days following onset of symptoms.
−Removed: Under the current EUA, the test is intended for use with nasopharyngeal (NP) samples in individuals suspected of COVID-19 infection by their healthcare providers.
−Removed: In September 2021, the FDA expanded the EUA for our Simoa SARS-CoV-2 N Protein Antigen Test to include testing with nasal swabs and saliva and for asymptomatic serial testing with nasal swab samples.
−Removed: We are exploring extending the test to home-based sample collection and pooling to enable larger scale testing.
Inflammation underlies the response of the body to injury in a variety of diseases.
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This has the potential to enable new discoveries into the role of inflammation in the biology of health and disease.
−Removed: Our Simoa technology measures low levels of inflammatory proteins, including cytokines and chemokines, that characterize a range
−Removed: of inflammatory diseases, including Crohn’s disease, asthma, rheumatoid arthritis and neuro-inflammation.
+Added: Our Simoa technology measures low levels of inflammatory proteins, including cytokines and chemokines, that characterize a range of inflammatory diseases, including Crohn’s disease, asthma, rheumatoid arthritis and neuro-inflammation.
We believe the sensitivity of Simoa technology can provide a clearer picture of the underlying state of the immune response and disease progression.
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By monitoring biomarkers indicative of response, clinicians may be able to adjust dose to reduce side effects or increase efficacy.
−Removed: Heart disease and related cardiovascular ailments remain the leading cause of death in the United States, contributing to nearly 1 in 4 deaths in the United States, according to the CDC.
−Removed: A significant need remains for early prediction of heart attacks and other cardiac events.
−Removed: Simoa’s highly sensitive digital measurement capabilities have the potential to be used to predict early cardiac disease.
Infectious Disease
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We believe that using Simoa to detect the toxins rather than the organism has the potential to provide a higher level of sensitivity and specificity, greatly reducing false positives.
+Added: Heart disease and related cardiovascular ailments remain the leading cause of death in the United States, contributing to nearly one in four deaths in the United States, according to the CDC.
+Added: A significant need remains for early prediction of heart attacks and other cardiac events.
+Added: Simoa’s highly sensitive digital measurement capabilities have the potential to be used to predict early cardiac disease.
Our Products and Services
12 unchanged sentences
Reader only, benchtop instrument with lower price point
−Removed: same sensitivity, dynamic range and homebrew capabilities as HD-X
+Added: Similar sensitivity, dynamic range and homebrew capabilities as HD-X
Multiplexing capability:
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Menu of approximately 36 single-plex and multi-plex bead-based assay kits includes assays for biomarkers in the areas of neurology, infectious disease, immunology and oncology
−Removed: Two EUA approved SARS-CoV-2 assays
Menu of Simoa planar array reagent kits includes approximately 115 biomarkers ranging from 1-10 analytes per assay in the areas of immunology and oncology research
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Proprietary Simoa disk with 24 arrays, each containing approximately 239,000 microwells for Simoa bead-based assays
−Removed: Nf-L antibodies and Nf-L ELISA kits
+Added: NfL antibodies and NfL ELISA kits
Sold through our wholly-owned subsidiary, Uman, which we acquired in 2019
−Removed: Nf-L capture/detection antibodies with unparalleled sensitivity and specificity
−Removed: Nf-L ELISA kits for CSF (CE-certified in Europe;
+Added: NfL capture/detection antibodies with unparalleled sensitivity and specificity
+Added: NfL ELISA kits for CSF (CE-certified in Europe;
RUO outside of Europe)
−Removed: Nf-L ELISA kits for serum (RUO)
−Removed: licensing and supply arrangement with Siemens Healthineers that will allow Siemens to begin developing blood-based Nf-L clinical tests for future commercialization
+Added: NfL ELISA kits for serum (RUO)
+Added: Licensing and supply arrangement with Siemens Healthineers that will allow Siemens to begin developing blood-based NfL clinical tests for future commercialization
Contract research services provided through our Accelerator Laboratory
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Extended warranty and service contracts
−Removed: CLIA-certified lab available
+Added: CLIA-certified lab available – LDT for pTau-181 launched in July 2022 and LDT for NfL launched in January 2023
Instruments and Consumables
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The HD-X uses our Simoa bead-based technology and is the most sensitive automated multiplex protein detection platform commercially available.
−Removed: Assays for the HD-X are fully automated (i.e., sample in to result out), and results for up to 66 samples are available in approximately one hour.
+Added: Assays for the HD-X are fully automated (i.e., from sample in to result out), and results for up to 66 samples are available in approximately one hour.
Samples can be input into the instrument via 96-well microtiter plates or sample tubes where the system can multiplex and process tests in a variety of assay protocol configurations.
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We commercially launched the SP-X instrument in April 2019.
−Removed: The SP-X uses the Simoa planar array technology developed initially by Aushon for multiplex chemiluminescent immunoassay measurement, which we refined by leveraging our proprietary sophisticated Simoa image analysis and data analysis algorithms to provide the same Simoa sensitivity found in our Simoa bead-based platform.
+Added: The SP-X uses the Simoa planar array technology developed initially by Aushon Biosystems (Aushon), which we acquired in 2018, for multiplex chemiluminescent immunoassay measurement, which we refined by leveraging our proprietary sophisticated Simoa image analysis and data analysis algorithms to provide sensitivity similar to that found in our Simoa bead-based platform.
The Simoa planar array technology utilizes a 96-well microtiter plate with up to 10 different assay measurements performed in each well of the plate from as little as 12.5 microliters of sample.
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The current menu of approximately 36 analyte-specific single-plex and multi-plex assay kits for our bead-based instruments includes assays for biomarkers in the areas of neurology, infectious disease, immunology and oncology for both human and mouse samples.
−Removed: The current menu of assay kits for the
−Removed: planar array instrument includes approximately 120 biomarkers ranging from 1-10 analytes per assay in the areas of immunology and oncology research.
+Added: The current menu of assay kits for the planar array instrument includes approximately 115 biomarkers ranging from 1-10 analytes per assay in the areas of immunology and oncology research.
In addition to these assays we have developed, both of the Simoa platforms allow ease and flexibility in assay design, enabling our customers to develop their own proprietary in-house assays, called homebrew assays, using our homebrew assay kits.
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We outsource some of our assay development activities to other antibody and/or assay development providers and expect to continue to do so to achieve our aggressive menu expansion goals.
−Removed: Nf-L Antibodies and Nf-L ELISA Kits
−Removed: In August 2019, we completed our acquisition of Uman.
−Removed: Uman supplies Nf-L antibodies and ELISA kits for Nf-L detection.
−Removed: Uman’s Nf-L antibodies are widely recognized by researchers and biopharmaceutical and diagnostics companies worldwide as the premier solution for the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
−Removed: Through Uman we sell proprietary Nf-L capture and detection antibodies, as well as two Nf-L ELISA kits for CSF, one of which is CE-certified in Europe, and one RUO Nf-L ELISA kit for serum.
+Added: NfL Antibodies and NfL ELISA Kits
+Added: Uman is our wholly owned subsidiary that supplies NfL antibodies and ELISA kits for NfL detection.
+Added: Uman’s NfL antibodies are widely recognized by researchers and biopharmaceutical and diagnostics companies worldwide as the premier solution for the detection of NfL to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
+Added: Through Uman we sell proprietary NfL capture and detection antibodies, as well as two NfL ELISA kits for CSF, one of which is CE-certified in Europe and one RUO NfL ELISA kit for serum.
Through our Accelerator Laboratory, which includes a CLIA-certified laboratory, we provide customers a contract research option.
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After identifying the optimal assay and conditions, the Accelerator Laboratory can be used to generate qualified bulk reagents or custom assay kits, providing customer access to validated kits for assays not yet commercially available on the Simoa platform.
−Removed: To date, we have completed over 1,700 projects for approximately 400 customers from all over the world using our Simoa platforms, including over 150 projects for clinical studies.
−Removed: In addition to being an important source of revenue, we have also found the Accelerator Laboratory to be a significant catalyst for placing additional instruments, as a number of customers for whom we have provided contract research services have subsequently purchased an instrument from us.
+Added: ● LDT Testing.
+Added: We have recently begun offering LDT testing through our CLIA-certified laboratory.
+Added: In July 2022, we launched an LDT to quantitatively measure pTau-181 in plasma as an aid in diagnostic evaluation of Alzheimer’s disease, and in January 2023, we launched an LDT to quantitatively measure NfL in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage.
+Added: To date, we have completed over 1,900 projects for more than 400 customers from all over the world using our Simoa platforms.
+Added: In addition to being an important source of revenue, we have also found the Accelerator Laboratory to be a catalyst for placing additional instruments, as a number of customers for whom we have provided contract research services have subsequently purchased an instrument from us.
We also generate revenues through extended-warranty and service contracts for our installed base of instruments.
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This evaluation includes examining new assay formats and instrumentation improvements and upgrades to increase the performance of our Simoa assays and instruments.
−Removed: We believe that sensitivity is so important that we have published an approach to increase the sensitivity of our Simoa technology – in some cases as much as 100-fold, and we intend to launch a beta program using this more sensitive technology in our Accelerator Laboratory by the end of 2022 .
−Removed: We are also focused on expanding our assay menu to extend the scope of applications for our platform and grow our customer base.
+Added: We also intend to selectively expand our assay menu to extend the scope of applications for our platform to biomarkers of significant
+Added: interest to the scientific community.
Our assay menu expansion is driven by a number of factors, including input from key opinion leaders, customer feedback, homebrew projects, Accelerator Laboratory projects, new publications on biomarkers of industry interest, and feedback from our sales and marketing team.
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We distribute our Simoa instruments and consumables via direct field sales and support organizations located in North America and Europe and through a combination of our own sales force and third-party distributors in additional major markets, including Australia, Brazil, China, Czech Republic, India, Hong Kong, Israel, Japan, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and UAE.
−Removed: In addition, we sell Uman’s Nf-L antibodies and Nf-L ELISA kits directly, and in conjunction with a distributor worldwide.
−Removed: Our domestic and international sales force informs our current and potential customers of current product offerings, new product and new assay introductions, and technological advances in Simoa systems, workflows, and notable research being performed by our customers or ourselves.
+Added: In addition, we sell Uman’s NfL antibodies and NfL ELISA kits directly and in conjunction with a distributor worldwide.
+Added: Our domestic and international sales force informs our current and potential customers of current product offerings, new product and new assay introductions, and technological advances in Simoa systems, workflows, and notable research being performed by our customers or us.
As our primary point of contact in the marketplace, our sales force focuses on delivering a consistent marketing message and high level of customer service, while also attempting to help us better understand evolving market and customer needs.
−Removed: As of December 31, 2021, we had 135 full-time people employed in sales, sales support and marketing, including technical field application scientists and field service personnel.
+Added: As of December 31, 2022, we had 125 full-time employees in sales, sales support and marketing, including technical field application scientists and field service personnel.
This staff is primarily located in North America and Europe.
−Removed: We intend to significantly expand our sales, support, and marketing efforts in the future by expanding our direct footprint in Europe as well as developing a comprehensive distribution and support network in China where significant new market opportunities exist.
+Added: We expect we will expand our sales, support, and marketing efforts in the future by expanding our direct footprint in Europe as well as developing a comprehensive distribution and support network in China where significant new market opportunities exist.
Additionally, we believe that there is significant opportunity in other Asia-Pacific region countries such as South Korea and Australia as well as in South America.
−Removed: We plan to expand into these regions via initial penetration with distributors and then subsequent support with Quanterix-employed sales and support personnel.
+Added: We are expanding into these regions via initial penetration with distributors and then subsequent support with Quanterix-employed sales and support personnel.
Our sales and marketing efforts are targeted at key opinion leaders, laboratory directors and principal investigators at leading biotechnology and pharmaceutical companies and governmental research institutions.
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We also seek to increase awareness of our products through participation at trade shows, academic conferences, online webinars and dedicated scientific events attended by prominent users and prospective customers.
−Removed: Our systems are relatively new to the life science marketplace and require a capital investment by our customers.
+Added: Our instruments require a capital investment by our customers.
The sales process typically involves numerous interactions and demonstrations with multiple people within an organization.
−Removed: Some potential customers conduct in-depth evaluations of the system including running experiments in the Accelerator Laboratory and comparing results from competing systems.
+Added: Some potential customers conduct in-depth evaluations of the instruments including running experiments in the Accelerator Laboratory and comparing results from competing systems.
In addition, in most countries, sales to academic or governmental institutions require participation in a tender process involving preparation of extensive documentation and a lengthy review process.
1 unchanged sentence
Manufacturing and Supply
−Removed: Our manufacturing strategy has two components:
−Removed: to outsource the Simoa bead-based instrument development and manufacturing with industry leaders, and to internally develop and manufacture our planar array instrument and all assay kits in our own facilities.
+Added: We outsource the development and manufacturing of our Simoa bead-based instruments to third-party manufacturers, and we develop and manufacture our planar array instrument and all assay kits in our own facilities.
The HD-X instrument is manufactured by STRATEC Biomedical AG (STRATEC), based in Birkenfeld, Germany, and is manufactured and shipped from their Birkenfeld and Beringen, Switzerland facilities.
−Removed: See “—Key Agreements—Development Agreement and Supply Agreement with STRATEC” for a description of our agreement with STRATEC.
The SR-X is manufactured by Paramit Corporation (Paramit), based in Morgan Hill, California, and is shipped to our global customers by Paramit.
−Removed: See “—Key Agreements—Paramit Manufacturing Services Agreement” for a description of our agreement with Paramit.
+Added: See “—Key Agreements” for a description of our agreements with STRATEC and Paramit.
Installation of, and training on, our instruments is provided by our employees in the markets where we conduct direct sales, and by distributors in those markets where we operate with distributors.
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The SP-X instruments are manufactured, tested, shipped and supported by us from our Billerica, Massachusetts facility.
−Removed: All internal components are sourced domestically except one significant component is sourced in Germany.
+Added: All internal components are sourced domestically except one significant component that is sourced in Germany.
These components are sourced from a limited number of suppliers, including certain single-source suppliers.
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Although we believe that alternatives would be available, it would take time to identify and validate replacement reagents for our assay kits, which could negatively affect our ability to supply assay kits on a timely basis.
−Removed: In an effort to mitigate this risk through inventory control, we have increased the shelf life of the vast majority of our bead-based assays from six months to 12 months or more.
+Added: In an effort to mitigate this risk through inventory control, we are working to increase the shelf life of our bead-based assays to 12 months or more.
Simoa disks for our bead-based platform are supplied through a single source supplier pursuant to a long-term supply agreement with STRATEC Consumables, a subsidiary of STRATEC Biomedical.
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Because our planar array assays have a shelf life of 12 months, we believe we are able to mitigate this risk through inventory control.
−Removed: Nf-L antibodies and Nf-L ELISA Kits
−Removed: The storage of Uman’s proprietary Nf-L antibody producing hybridomas as well as the cultivation and purification of the antibodies is outsourced to a contract manufacturer, and bulk material of purified antibodies is delivered to Uman’s site in Umeå, Sweden.
+Added: NfL antibodies and NfL ELISA Kits
+Added: The storage of Uman’s proprietary NfL antibody producing hybridomas as well as the cultivation and purification of the antibodies is outsourced to a contract manufacturer, and bulk material of purified antibodies is delivered to Uman’s site in Umeå, Sweden.
Functional testing and verification of concentration are performed at Uman before the material is approved for use in production activities.
−Removed: The antibodies can be aliquoted and sold as single reagents or used for the production of Uman’s Nf-L ELISA kits.
+Added: The antibodies can be aliquoted and sold as single reagents or used for the production of Uman’s NfL ELISA kits.
The antibody reagents are labeled and released to market after testing.
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The current shelf-life of the antibodies is 18 months.
−Removed: All components in Uman’s Nf-L ELISA kits are manufactured in-house at Uman from starting materials sourced from suppliers that have been evaluated and approved.
+Added: All components in Uman’s NfL ELISA kits are manufactured in-house at Uman from starting materials sourced from suppliers that have been evaluated and approved.
Uman has entered into supply agreements with critical suppliers.
All incoming goods are subject to receipt control and any deviations related to quality deficiencies are registered.
−Removed: The kit components include buffers (sample diluent and wash solution), an ELISA 96-well plate coated with a capture antibody, detector antibody, streptavidine conjugate, substrate (TMB) and stop reagent.
+Added: The kit components include buffers (sample diluents and wash solutions), ELISA 96-well plates coated with a capture antibody, detector antibodies, streptavidine conjugates, substrates (TMB) and stop reagents.
The kit components are labeled (either RUO or CE) and assembled.
−Removed: The final ELISA kit product is subject to quality control which include testing of human CSF quality control samples to assure a high batch consistency.
+Added: The final ELISA kit products are subject to quality control procedures, which include
+Added: testing of human CSF or human serum quality control samples to assure a high batch consistency.
After testing and batch record review, the material is released to market.
−Removed: The current shelf-life of the kits is 18 months.
+Added: The current shelf-life of the kits is 18 months (NF-light ELISA (CSF)) or 13 months (NF-light Serum ELISA).
Key Agreements
Development Agreement and Supply Agreement with STRATEC
−Removed: In August 2011, we entered into a Strategic Development Services and Equity Participation Agreement (the STRATEC Development Agreement) with STRATEC, pursuant to which STRATEC undertook the development of the Simoa HD instrument.
−Removed: Under the STRATEC Development Agreement, we were required to pay a fee and issue to STRATEC warrants to purchase our equity securities, all of which have been exercised as of December 31, 2017.
−Removed: These fees and warrants were subject to a milestone based payment schedule.
−Removed: The STRATEC Development Agreement was amended in November 2016.
−Removed: The Amendment reduced our obligation to satisfy a minimum purchase commitment under the STRATEC Supply Agreement described below.
−Removed: Additionally, the parties agreed on additional development services for an additional fee, which is payable when the additional development is completed.
−Removed: This fee includes the final milestone payment that was associated with the final milestone due under the terms of the STRATEC Development Agreement.
−Removed: The services were completed in and the final milestone payment was paid in the fourth quarter of 2019.
−Removed: The STRATEC Development Agreement may be terminated on the insolvency of a party, for an uncured material breach, or, by us, on a change of control of our company (subject to certain obligations to compensate STRATEC on such termination) or if we and STRATEC are unable to agree on pricing of the instrument, within certain parameters.
+Added: In August 2011, we entered into a Strategic Development Services and Equity Participation Agreement with STRATEC, pursuant to which STRATEC undertook the development of the Simoa HD instrument.
In September 2011, we also entered into a Supply and Manufacturing Agreement with STRATEC (the STRATEC Supply Agreement), pursuant to which STRATEC agreed to supply HD instruments to us, and we agreed to procure those instruments exclusively from STRATEC, subject to STRATEC’s ability to supply the instruments.
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The instrument price stipulated in the STRATEC Supply Agreement was established based on certain specified assumptions and is subject to certain adjustments.
−Removed: The STRATEC Supply Agreement is terminable by either party on 12 months’ notice to the other party, provided that neither party may terminate the STRATEC Supply Agreement prior to the later of the seven year anniversary of the acceptance of the first prototype instrument and the purchase of the minimum number of instruments which we were committed to procure.
+Added: The STRATEC Supply Agreement is terminable by either party on 12 months’ notice to the other party.
The STRATEC Supply Agreement may also be terminated on the insolvency of a party or the uncured material breach of a party, or, by us, on a change of control of our company (subject to certain obligations to compensate STRATEC on such termination).
−Removed: On termination by us for STRATEC’s insolvency or uncured material breach or termination by STRATEC for convenience, we are granted a nonexclusive royalty free
−Removed: license of STRATEC intellectual property to manufacture the instruments.
−Removed: In certain of these circumstances, we could be obligated to issue warrants to purchase common stock.
+Added: On termination by us for STRATEC’s insolvency or uncured material breach or termination by STRATEC for convenience, we are granted a nonexclusive royalty free license of STRATEC intellectual property to manufacture the instruments.
+Added: In certain of these circumstances, we could be obligated to issue warrants to purchase our common stock.
Paramit Manufacturing Services Agreement
1 unchanged sentence
Under the terms of the Paramit Agreement, we engaged Paramit to produce and test our SR-X instrument on an as-ordered basis.
−Removed: We also engaged Paramit to supply spare parts.
+Added: We also engaged Paramit to supply spare parts for the SR-X instrument.
Paramit has no obligation to manufacture our instrument without a purchase order and no obligation to maintain inventory in excess of any open purchase orders or materials in excess of the amount Paramit reasonably determines will be consumed within 90 days or within the lead time of manufacturing our instrument, whichever is greater.
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The parties agreed to review the pricing methodology yearly or upon a material change in cost.
−Removed: The Paramit Agreement has an initial three-year term with automatic one year extensions.
+Added: The Paramit Agreement had an initial three-year term with automatic one year extensions.
It is terminable by either party for convenience with written notice to the other party given at least nine months prior to the end of the then-current term.
1 unchanged sentence
The Paramit Agreement is terminable by Paramit with 30 days’ notice to us in the event of a material breach after written notice and a 60-day opportunity to cure the breach.
−Removed: Non-Exclusive License Agreement with Abbott Laboratories
−Removed: In September 2020, we entered into a Non-Exclusive License Agreement with Abbott.
−Removed: Pursuant to the terms of the License Agreement, we granted Abbott a non-exclusive, worldwide, royalty-bearing license, without the right to sublicense, under our bead-based single molecule detection patents in the field of IVD.
−Removed: Abbott paid us an initial license fee of $10.0 million in connection with the execution of the License Agreement.
−Removed: Abbott has also agreed to pay us milestone fees subject to the achievement by Abbott of certain development, regulatory and commercialization milestones and low single digit royalties on net sales of licensed products.
−Removed: The License Agreement includes customary representations and warranties, covenants and indemnification obligations for a transaction of this nature.
−Removed: The License Agreement became effective upon signing and will continue until expiration of the last-to-expire licensed patent, or the agreement is earlier terminated.
−Removed: Under the terms of the License Agreement, each party has the right to terminate the agreement for uncured material breach by, or insolvency of, the other party.
−Removed: Abbott may also terminate the License Agreement at any time without cause upon sixty (60) days’ notice.
−Removed: Contracts with the NIH under RADx
−Removed: In September 2020, we entered into the Rapid Acceleration of Diagnostics (RADx) workplan 2 award (WP2) with the National Institute of Health (NIH) under the RADx program.
−Removed: This contract, which has a total award value of up to $18.2 million, is intended to accelerate the continued development, scale-up and deployment of our novel SARS-CoV-2 antigen test.
−Removed: Initial early feasibility of this test was funded in part through the RADx workplan 1 award (WP1) we were granted in June 2020.
−Removed: WP2 supports clinical validation of the test in support of the EUA submissions with the FDA, and provides funding to expand assay kit manufacturing capacity and commercial deployment readiness.
−Removed: Contract funding was subject to achievement of pre-defined milestones and the contract period ran through September 2021, with one milestone extended to March 31, 2022.
−Removed: As of December 31, 2021, we had received $17.7 million out of the full $18.2 million under WP2.
−Removed: We compete with both established and development-stage life science companies that design, manufacture and market instruments for protein discovery, detection, nucleic acid detection and additional applications.
−Removed: For example, companies such as Bio-Techne, Luminex, MesoScale Discovery, Gyros, Nanostring, O-Link, SEER, Somalogic, MilliporeSigma, Bio-Rad Laboratories, Thermo Fisher Scientific, and others, have products for protein discovery or detection that compete in certain segments of the market in which we sell our products.
−Removed: Our Accelerator Laboratory competes with other research laboratories such as Covance, Q2 Solutions, Myriad RBM, Monogram Biosciences, PPD Laboratories, and others, some of whom are customers of ours.
−Removed: In addition, as we or our partners expand the applications for our products to include diagnostics and precision health screening, we expect to compete with companies such as Siemens, Abbott, Roche, Ortho Clinical Diagnostics and Thermo Fisher Scientific.
+Added: We compete with both established and development-stage life science companies that design, manufacture and market instruments for proteomics discovery and clinical research applications.
+Added: For example, companies such as Bio-Techne, Luminex, MesoScale Discovery, Gyros, O-Link, SEER, Somalogic, MilliporeSigma, Bio-Rad Laboratories, Thermo Fisher Scientific, and others, have products for protein measurements in biofluids that compete in certain segments of the market in which we sell our products.
+Added: Our Accelerator Laboratory competes with other research
+Added: laboratories such as Covance, Q2 Solutions, Rules Based Medicine, Monogram Biosciences, PPD Laboratories, and others, some of whom are customers of ours.
+Added: In addition, as we or our partners expand the applications for our products to include diagnostics, we expect to compete with companies such as Siemens, Abbott, Roche, Ortho Clinical Diagnostics and Thermo Fisher Scientific.
Furthermore, our technology and products are showing promise for non-invasive early disease detection, and in the future, we could experience competition from companies that develop and market imaging and other molecular detection technologies.
−Removed: In addition, a number of other companies and academic groups are in the process of developing novel technologies for the life science research, diagnostic and precision health screening markets.
+Added: In addition, a number of other companies and academic groups are in the process of developing novel technologies for the life science research and diagnostic markets.
Many of the companies with which we compete or will compete have substantially greater resources than we have.
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The fourth layer is concerned with specific uses of the core technology (e.g., biomarkers and diagnostics).
−Removed: Our patent strategy is both offensive and defensive in nature;
−Removed: seeking to protect not only technology we currently practice but also alternative, related embodiments.
+Added: Our patent strategy is both offensive and defensive in nature, seeking to protect not only technology we currently practice but also alternative, related embodiments.
Simoa and Related Technology
−Removed: As of February 1, 2022, we had exclusively licensed 18 patents and two patent applications from Tufts.
−Removed: These patents and patent applications include nine issued U.S.
+Added: As of March 1, 2023, we had exclusively licensed 17 patents and two patent applications from Tufts.
+Added: These patents and patent applications include eight issued U.S.
patents and two pending U.S.
11 unchanged sentences
patent in this family is August 22, 2025.
−Removed: A third patent family licensed from Tufts is directed to electro-optical systems including an array and a plurality of electrodes.
−Removed: This patent family includes one granted U.S.
−Removed: The standard patent expiration date for the U.S.
−Removed: patent in this family is February 14, 2023.
−Removed: A fourth patent family licensed from Tufts is directed to methods for detecting short nucleic acids.
+Added: A third patent family licensed from Tufts is directed to methods for detecting short nucleic acids.
This patent family includes one pending U.S.
patent application.
−Removed: The standard patent expiration date for the U.S.
−Removed: patent in this family is May 29, 2039.
−Removed: As of February 1, 2022, we owned 27 issued U.S.
+Added: The standard patent expiration date for any U.S.
+Added: patents that may issue in this family is May 29, 2039.
+Added: As of March 1, 2023, we owned 29 issued U.S.
patents and 17 pending U.S.
−Removed: patent applications, six granted European patents and three pending European patent applications, six granted Japanese patents, four granted Chinese patents and one pending Chinese patent application, three granted Canadian patents and one pending Canadian patent application, two registered Hong Kong patent applications, and one Patent Cooperation Treaty Application.
+Added: patent applications, eight granted European patents and three pending European patent applications, six granted Japanese patents and one pending Japanese patent application, four granted Chinese patents and two pending Chinese patent application, four granted Canadian patents and one pending Canadian patent application, and one registered Hong Kong patent application.
A first patent family owned by us is directed to methods for determining a measure of the concentration of analyte molecules or particles in a fluid sample, and in particular to methods for analyte capture on beads, including multiplexing.
23 unchanged sentences
patents and one pending U.S.
−Removed: patent application, two granted Japanese patents, one granted Chinese patent and one pending Chinese patent applications, one registered Hong Kong patent application and one pending patent application in each of Europe and Canada.
−Removed: The standard patent expiration date for any U.S.
−Removed: patents that may issue from this family is February 25, 2031, and for any non-U.S.
+Added: patent application, one granted European patent (nationalized and active in eleven countries) and one pending European patent application, two granted Japanese patents, one granted Chinese patent and one pending Chinese patent applications, one registered Hong Kong patent application, and one granted
+Added: Canadian patent.
+Added: The standard patent expiration date for the U.S.
+Added: patents in this family is February 25, 2031, and for any non-U.S.
patents is January 27, 2032.
15 unchanged sentences
A ninth patent family owned by us is directed to methods and systems for highly sensitive assays, including methods and systems for improving capture object loading efficiency and/or use of low numbers of capture objects in assays.
−Removed: This patent family includes one pending Patent Cooperation Treaty patent application.
−Removed: If we pursue protection by filing any national stage applications, the standard patent expiration date for any patents that may issue from this family will be in 2041.
−Removed: We own or co-own ten patent families directed to the measurement of particular types of analytes, including β-amyloid peptide, tau protein, toxin B of C.
+Added: This patent family includes one pending U.S.
+Added: patent application, one pending European patent application, one pending Japanese patent application, one pending Chinese patent application, and one pending Canadian patent application.
+Added: The standard patent expiration date for any patents that may issue from this family is April 14, 2041.
+Added: In addition to the nine patent families described above, we own or co-own nine additional patent families directed to the measurement of particular types of analytes, including β-amyloid peptide, tau protein, toxin B of C.
difficile , neurofilament light, glial fibrillary acidic protein, ubiquitin carboxyl-terminal hydrolase L1, antigens from infectious organisms such as viruses (e.g., coronaviruses), and DNA or RNA molecules.
−Removed: These families include one granted U.S.
−Removed: patent directed to methods for determining treatment protocols and/or a prognosis of a patient’s recovery from a brain injury based on measurements of tau protein in blood and one granted European patent (nationalized and active in three countries) directed to detection of C.
+Added: Among the granted patents and pending patent applications in these nine families are two granted U.S.
+Added: patents directed to methods for determining treatment protocols and/or a prognosis of a patient’s recovery from a brain injury based on measurements of tau protein in blood and one granted U.S.
+Added: patent and one granted European patent (nationalized and active in three countries) directed to detection of C.
Any patents that may issue from these patent applications would have standard expiration dates between 2032 and 2041.
With the acquisition of Aushon in January 2018, we acquired their patent portfolio for our planar array technology.
−Removed: As of February 1, 2022, the acquired patent portfolio includes at least ten issued U.S.
+Added: As of March 1, 2023, the acquired patent portfolio includes at least ten issued U.S.
patents and one pending U.S.
−Removed: patent application, one granted Canadian patent, one granted European patent (nationalized and active in eight countries) and one pending European patent application, and one registered Hong Kong patent.
+Added: patent application, one granted Canadian patent, and two granted European patents (nationalized and active in eight countries).
We have licensed additional patents and patent applications from third parties.
+Added: These include a portfolio of patent filings we licensed from Harvard University directed to additional single molecule assay technologies originated in the laboratory of Professor David Walt, who is the founder of Quanterix and a current member of our Board of Directors.
+Added: A first patent family exclusively licensed by us from Harvard University is directed to assays that provide digital measurement methods to detect proteins and other biomolecules, e.g., at low- to mid-attomolar concentrations.
+Added: This patent family includes one pending International Patent Application.
+Added: The standard patent expiration date for any patents that may issue from this family is June 22, 2041.
+Added: A second patent family exclusively licensed by us from Harvard University is directed to single molecule assays for ultrasensitive detection of analytes.
+Added: The standard patent expiration date for any patents that may issue from this family will be in 2042.
+Added: A third patent family exclusively licensed by us from Harvard University is directed to high-sensitivity methods for detection and quantification of target analytes in liquid samples (e.g., biological or environmental samples).
+Added: The standard patent expiration date for any patents that may issue from this family is August 15, 2039.
+Added: A fourth patent family non-exclusively licensed by us from Harvard University is directed to methods and compositions to detect Mycobacterium tuberculosis antigens, e.g., lipoarabinomannan (LAM) and/or Ag85B (Rv1886c), in a sample (e.g., a human urine sample) for diagnosis of tuberculosis.
+Added: The standard patent expiration date for any patents that may issue from this family is December 17, 2040.
In addition to pursuing patents on our technology, we have taken steps to protect our intellectual property and proprietary technology by entering into confidentiality agreements and intellectual property assignment agreements with our employees, consultants, corporate partners and, when needed, our advisors.
12 unchanged sentences
Government Regulation
−Removed: Other than the COVID assays for which we have received EUAs, our products are currently intended for research use only (RUO) applications, although our customers may use our products to develop their own products that are subject to regulation by the FDA or the Center for Medicare and Medicaid Services (CMS).
−Removed: Although most products intended for RUO are not currently subject to clearance or approval by the FDA, RUO products are subject to FDA’s premarket review requirements if they are determined to be intended for use for clinical rather than research purposes.
−Removed: Consequently, our products (other than the COVID assays for which we have received EUAs) are labeled “For Research Use Only.”
−Removed: On November 25, 2013, the FDA issued Final Guidance for Industry and Food and Drug Administration Staff on “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (RUO/IUO Guidance).
−Removed: The purpose of an FDA guidance document is to provide the FDA’s current thinking on when IVD products are properly labeled for RUO or for IUO, but as with all FDA guidance documents, this guidance does not establish legally enforceable responsibilities and should be viewed as recommendations unless specific regulatory or statutory requirements are cited.
+Added: The majority of our products are currently intended for research use only (RUO) applications, although our customers may use our products to develop their own products that are subject to regulation by the FDA or the Center for Medicare & Medicaid Services (CMS).
+Added: Although most in vitro diagnostic products intended for RUO are not currently required to obtain premarket clearance or approval by the FDA, products labeled as RUO are subject to the FDA’s premarket review requirements if they are determined to be intended for use for clinical rather than research purposes.
+Added: Consequently, other than our two laboratory developed tests intended for clinical testing, our products are labeled and intended “For Research Use Only.
+Added: Not for Diagnostic Procedures.”
+Added: The FDA has issued Final Guidance for Industry and Food and Drug Administration Staff on “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only” (the RUO/IUO Guidance).
+Added: The purpose of an FDA guidance document is to provide the FDA’s current thinking on when IVD products are properly labeled for RUO or for investigational use only (IUO) and when products labeled RUO or IUO will be viewed by the FDA as intended for clinical use, but as with all FDA guidance documents, this guidance does not establish legally enforceable responsibilities and should be viewed as recommendations unless specific regulatory or statutory
+Added: requirements are cited.
The RUO/IUO Guidance explains that the FDA will review the totality of the circumstances when evaluating whether equipment and testing components are properly labeled as RUO.
−Removed: Merely including a labeling statement that a product is intended for research use only will not necessarily exempt the device from the FDA’s 510(k) clearance, premarket approval, or other requirements, if the circumstances surrounding the distribution of the product indicate that the manufacturer intends its product to be used for clinical diagnostic use.
+Added: Merely including a labeling statement that a product is intended for research use only will not necessarily exempt the device from the FDA’s premarket notification and clearance process (510(k)), premarket approval, or other requirements, if the circumstances surrounding the distribution of the product indicate that the manufacturer intends its product to be used for clinical diagnostic use.
These circumstances may include written or verbal marketing claims or links to articles regarding a product’s performance in clinical applications, a manufacturer’s provision of technical support for clinical validation or clinical applications, or solicitation of business from clinical laboratories, all of which could be considered evidence of intended uses that conflict with RUO labeling.
−Removed: Although the RUO/IUO Guidance is a statement of the FDA’s thinking with respect to certain RUOs and IUOs in 2013 and was not intended as a compliance requirement, we believe that our labeling and
−Removed: promotion of our products, including the custom assay RUO products developed by the Accelerator Laboratory, is consistent with the RUO/IUO Guidance because we have not promoted our products for clinical use in humans.
−Removed: We also are not promoting or using our products in the development or promotion of laboratory developed test (LDT) services.
−Removed: When we develop products for clinical use, we will do so in accordance with FDA requirements applicable to those products at that time.
−Removed: Separately, when we become aware that accredited or licensed clinical laboratories may be using our RUO products either for research or clinical uses, such as part of LDT services, in accordance with the regulations that apply to clinical laboratories, we will continue to review the labeling and promotion of our products for consistency with the RUO/IUO Guidance.
−Removed: When our products are marketed for clinical diagnostic use, our products will be regulated by the FDA as medical devices.
+Added: Although the RUO/IUO Guidance was not intended as a compliance requirement, we believe that our labeling and promotion of our products, including the custom assay RUO products developed by the Accelerator Laboratory, is consistent with the RUO/IUO Guidance because we have not promoted our products for clinical use in humans.
+Added: IVD tests intended for clinical diagnostic use are regulated by the FDA as medical devices, however, the FDA has traditionally not regulated certain laboratory tests referred to as laboratory developed tests (LDTs) (as discussed further below).
The FDA defines a medical device in part as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article which is intended for the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man.
−Removed: This means that the FDA will regulate the development, testing, manufacturing, marketing, post-market surveillance, distribution, advertising and labeling of our clinical products and we will be required to register as a medical device manufacturer and list our marketed products.
+Added: This means that the FDA will regulate the development, testing, manufacturing, marketing, post-market surveillance, distribution, advertising and labeling of our clinical IVD devices (other than our LDTs) and we will be required to register as a medical device manufacturer and list our marketed products.
The FDA classifies medical devices into one of three classes on the basis of the intended use of the device, the risk associated with the use of the device for that indication, as determined by the FDA, and on the controls deemed by the FDA to be necessary to reasonably ensure their safety and effectiveness.
Class I devices, which have the lowest level of risk associated with them, are subject to general controls.
−Removed: Class II devices are subject to general controls and special controls, including performance standards.
−Removed: Class III devices, which have the highest level of risk associated with them, are subject to general controls and premarket approval.
−Removed: Most Class I devices and some Class II devices are exempt from a requirement that the manufacturer submit a premarket notification (510(k)) and receive clearance from the FDA which is otherwise a premarketing requirement for a Class II device.
+Added: Class II devices are subject to general controls and special controls, including performance standards and guidance documents setting out labeling and testing requirements.
+Added: Class III devices, which have the highest level of risk associated with them, are subject to general controls and premarket approval, including any conditions imposed as part of the approval.
+Added: Most Class I devices and some Class II devices are exempt from a requirement that the manufacturer submit a premarket notification (510(k)) and receive clearance from the FDA, which is otherwise a premarketing requirement for Class I and Class II devices that are not exempt.
Class III devices may not be commercialized until a premarket approval application (PMA) is submitted to and approved by the FDA.
+Added: Novel devices that have not been classified require either approval of a PMA or FDA review of a de novo classification request before they can be marketed.
510(k) Clearance Pathway
−Removed: To obtain 510(k) clearance, a sponsor must submit to the FDA a premarket notification demonstrating that the device is substantially equivalent (SE), to a device legally marketed in the U.S.
+Added: To obtain 510(k) clearance for Class I and Class II devices that are not exempt, a sponsor must submit to the FDA a premarket notification demonstrating that the device is substantially equivalent (SE) to a predicate device legally marketed in the U.S.
for which a PMA was not required.
−Removed: The FDA is supposed to make a SE determination within 90 days of FDA’s receipt of the 510(k), but it often takes longer if the FDA requests additional information.
+Added: Substantial equivalence means that the device has the same intended use as the predicate device and either (a) has the same technological characteristics as the predicate device or (b) has different technological characteristics but does not raise difference questions of safety and effectiveness and information in the premarket notification demonstrates the device is as safe and effective as the predicate.
+Added: The FDA is supposed to make a SE determination within 90 days of the FDA’s receipt of the 510(k), but it often takes longer if the FDA requests additional information.
Most 510(k)s do not require supporting data from clinical trials, but the FDA may request such data.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, will require a new clearance or possibly a pre-market approval.
−Removed: De Novo Classification
−Removed: Medical device types that the FDA has not previously classified as Class I, II or III are automatically classified into Class III regardless of the level of risk they pose.
−Removed: The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure.
−Removed: This procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application.
−Removed: Prior to the enactment of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the FDA that the device was not substantially equivalent.
−Removed: FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination.
−Removed: Under FDASIA, the FDA is required to classify the device within 120 days following receipt of the de novo application.
−Removed: If the manufacturer seeks
−Removed: reclassification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device.
−Removed: In addition, the FDA may reject the reclassification petition if it identifies a legally marketed predicate device that would be appropriate for a 510(k) or determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and special controls cannot be developed.
Premarket Approval Pathway
1 unchanged sentence
The PMA process is generally more complex, costly and time consuming than the 510(k) process.
−Removed: A PMA must be supported by extensive data including, but not limited to, technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device for its intended use.
+Added: A PMA must be supported by extensive data including, but not limited to, technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the
+Added: FDA’s satisfaction a reasonable assurance that the device is safe and effective for its intended use.
After a PMA is sufficiently complete, the FDA will accept the application for filing and begin an in-depth review of the submitted information.
5 unchanged sentences
New premarket approval applications or premarket approval application supplements are also required for product modifications that affect the safety and efficacy of the device.
+Added: De Novo Classification
+Added: Medical device types that the FDA has not previously classified as Class I, II or III are automatically classified into Class III regardless of the level of risk they pose.
+Added: However, a de novo classification request allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application.
+Added: Prior to the enactment of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the FDA that the device was not substantially equivalent.
+Added: FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination.
+Added: Under FDASIA, the FDA is required to classify the device within 120 days following receipt of the de novo classification request, but the review often takes longer if the FDA requests additional information.
+Added: If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device.
+Added: In addition, the FDA may reject the reclassification petition if it identifies a legally marketed predicate device that would be appropriate for a 510(k) or determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and special controls cannot be developed.
Emergency Use Authorization
In emergency situations, such as a pandemic, the FDA has the authority to allow unapproved medical products or unapproved uses of cleared or approved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear warfare threat agents when there are no adequate, approved, and available alternatives.
−Removed: Under this authority, the FDA may issue an EUA for an unapproved device if the following four statutory criteria have been met:
+Added: Under this authority, the FDA may issue an emergency use authorization (EUA) for an unapproved device if the following four statutory criteria have been met:
(1) a serious or life-threatening condition exists;
3 unchanged sentences
Evidence of effectiveness includes medical devices that “may be effective” to prevent, diagnose, or treat the disease or condition identified in a declaration of emergency issued by the Secretary of the Department of Health and Human Services (HHS).
−Removed: The “may be effective” standard for EUAs requires a lower level of evidence than the “effectiveness” standard that FDA uses for product clearances or approvals in non-emergency situations.
+Added: The “may be effective” standard for EUAs requires a lower level of evidence than the “effectiveness” standard that FDA uses for product approvals in non-emergency situations.
The FDA assesses the potential effectiveness of a possible EUA product on a case-by-case basis using a risk-benefit analysis.
4 unchanged sentences
The FDA also may revise or revoke an EUA if the circumstances justifying its issuance no longer exist, the criteria for its issuance are no longer met, or other circumstances make a revision or revocation appropriate to protect the public health or safety.
−Removed: On January 31, 2020, the Secretary of HHS issued a declaration of a public health emergency related to COVID-19.
−Removed: On February 4, 2020, HHS determined that COVID-19 represents a public health emergency that has a significant potential to affect national security or the health and security of U.S.
−Removed: citizens living abroad and, subsequently, declared on March 24, 2020, that circumstances exist to justify the authorization of emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 pandemic, subject to the terms of any authorization as issued by the FDA.
−Removed: On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to development of IVD tests during the COVID-19 public health emergency.
−Removed: This guidance was updated on March 16, 2020, May 4, 2020, and May 11, 2020.
Clinical Trials
−Removed: Clinical trials are usually required to support a PMA and are sometimes required for a 510(k).
−Removed: In the U.S., if the device is determined to present a “significant risk,” the manufacturer may not begin a clinical trial until it submits an investigational device exemption application (IDE) and obtains approval of the IDE from the FDA.
−Removed: These clinical trials are also subject to the review, approval and oversight of an institutional review board (IRB) at each clinical trial site.
+Added: Clinical trials are usually required to support a PMA and are sometimes required for a 510(k) or a de novo classification request.
+Added: In the U.S., if the device is determined to present a “significant risk,” the manufacturer may not begin a clinical trial until it submits an investigational device exemption (IDE) application and obtains approval of the IDE from the FDA.
+Added: Non-significant risk device studies do not require FDA approval of an IDE application.
+Added: Both significant risk and non-significant risk clinical trials are also subject to the review, approval and oversight of an institutional review board (IRB).
The clinical trials must be conducted in accordance with the FDA’s IDE regulations and good clinical practices.
−Removed: A clinical trial may be suspended by FDA, the sponsor or an IRB at its institution at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation in the trial.
+Added: A clinical trial may be suspended by the FDA, the sponsor or an IRB at its institution at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation in the trial.
Even if a clinical trial is completed, the results may not demonstrate the safety and efficacy of a device to the satisfaction of the FDA, or may be equivocal or otherwise not be sufficient to obtain approval of a device.
+Added: Clinical trials are also subject to a requirement to submit certain information to the ClincialTrials.gov database maintained by the National Institutes of Health.
Breakthrough Device Designation
2 unchanged sentences
The Breakthrough Devices Program offers device companies an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help companies receive feedback from the FDA and identify areas of agreement in a timely way.
−Removed: Recipients may also receive prioritized review of their submission and potential Medicare reimbursement through the Medicare Coverage of Innovative Technology payment pathway.
+Added: Recipients may also receive prioritized review of their submission.
Although Breakthrough Device designation or access to any other expedited program may expedite the development or clearance/authorization/approval process, it is not guaranteed to do so, and, more importantly, it does not change the standards for clearance/authorization/approval.
4 unchanged sentences
● establishment registration and device listing;
−Removed: ● the QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
+Added: ● the QSR, which requires manufacturers, including third-party contract manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
● labeling regulations and the FDA prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses and other requirements related to promotional activities;
−Removed: ● medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury, or if their device malfunctioned and the device
−Removed: or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;
+Added: ● medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury, or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;
● corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the Federal Food, Drug, and Cosmetics Act that may present a risk to health;
5 unchanged sentences
operating restrictions, partial suspension or total shutdown of production;
−Removed: refusal to grant 510(k) clearance or PMA approvals of new devices;
−Removed: withdrawal of 510(k) clearance or PMA approvals;
+Added: refusal to grant PMA approvals of new devices;
+Added: withdrawal of PMA approvals;
and civil or criminal prosecution.
Clinical Laboratory Improvement Amendments of 1988, Regulation of LDTs and State Regulation
−Removed: Since our acquisition of Aushon in January 2018, we own and operate a CLIA certified laboratory.
−Removed: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States (with the exception of clinical trials and basic research).
−Removed: A clinical laboratory is defined by CLIA as any facility that performs laboratory testing on specimens obtained from humans for the purpose of providing information for health assessment and for the diagnosis, prevention, or treatment of disease.
+Added: We own and operate a CLIA-certified laboratory.
+Added: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States (with the exception of research testing that does not report patient specific results).
+Added: A clinical laboratory is defined by CLIA as any facility that performs laboratory testing on specimens obtained from humans for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings.
CLIA requires such laboratories to be certified by the federal government and mandates compliance with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely.
CLIA certification also is a prerequisite to be eligible to bill state and federal health care programs, as well as many private insurers, for laboratory testing services.
−Removed: In addition, CLIA requires certified laboratories to enroll in an approved proficiency testing program if performing testing in any category for which proficiency testing is required.
−Removed: If a laboratory fails to achieve a passing score on a proficiency test, then it loses its right to perform testing.
−Removed: As a condition of CLIA certification, laboratories are subject to survey and inspection every other year, in addition to being subject to additional random inspections.
−Removed: The biennial survey is conducted by the Centers for Medicare & Medicaid Services (“CMS”), a CMS agent (typically a state agency), or, a CMS-approved accreditation organization.
+Added: In addition, CLIA requires certified laboratories to enroll in an approved proficiency testing program for each of the specialties and subspecialties for which it is certified.
+Added: If a laboratory fails to achieve a passing score on a proficiency test, then its CLIA certificate may be suspended, limited or revoked, or other sanctions may be imposed.
+Added: As a condition of CLIA certification, laboratories are subject to survey and inspection every other year (except laboratories with only a certificate of waiver or certificate of provider-performed microscopy procedures are not subject to biennial inspections), in addition to being subject to additional random inspections.
+Added: The biennial survey is conducted by CMS, a CMS agent (typically a state agency), or a CMS-approved accreditation organization.
High complexity, CLIA-certified laboratories, such as ours, frequently develop testing procedures to provide diagnostic results to customers.
−Removed: These tests have been traditionally offered by nearly all complex laboratories for the last few decades as LDTs, which are subject to CMS oversight through its enforcement of CLIA.
−Removed: The FDA also has claimed that it has regulatory authority over LDTs, but has not exercised enforcement with respect to most LDTs offered by high complexity laboratories, and not sought to require these laboratories to comply with FDA regulations regarding medical devices.
−Removed: During 2010, the FDA publicly announced that it had decided to exercise regulatory authority over these LDTs, and that it planned to issue guidance to the industry regarding its regulatory approach.
+Added: These tests have been traditionally offered by high-complexity laboratories for the last few decades as LDTs, the validation and performance of which are subject to CMS oversight through its enforcement of CLIA.
+Added: The FDA also has claimed that it has regulatory authority over LDTs under the agency’s medical device authorities, but has not exercised enforcement with respect to most LDTs offered by high complexity laboratories, and not sought to require these laboratories to comply with FDA regulations regarding medical devices.
+Added: In 2010, the FDA announced that it had decided to exercise regulatory authority over these LDTs, and that it planned to issue guidance to the industry regarding its regulatory approach.
At that time, the FDA indicated that it would use a risk-based approach to regulation and would direct more resources to tests with wider distribution and with the highest risk of injury, but that it would be sensitive to the need to not adversely impact patient care or innovation.
−Removed: In September 2014, the FDA announced its framework and timetable for implementing this guidance.
−Removed: On November 18, 2016, the FDA announced it would not release final guidance at that time and instead would continue to work with stakeholders, the new administration and Congress to determine the right approach.
−Removed: On January 3, 2017, the FDA released a discussion paper outlining a possible risk-based approach for FDA and CMS oversight of LDTs.
−Removed: Later in 2017, the FDA indicated that Congress should enact legislation to address improved oversight of diagnostics, including LTDs, rather than the FDA addressing the issue through administrative proposals.
−Removed: We cannot predict the ultimate timing or form of any such guidance or regulation or their potential impact.
−Removed: If adopted, such a regulatory
−Removed: approach by the FDA may lead to an increased regulatory burden, including additional costs and delays in introducing new tests.
−Removed: While the ultimate impact of the FDA’s approach is unknown, it may be extensive and may result in significant change.
+Added: To date, the FDA has not issued such guidance, and has indicated that Congress should enact legislation to address improved oversight of diagnostics,
+Added: including LDTs, rather than the FDA addressing the issue through administrative proposals.
+Added: However, FDA has increased its oversight of what it perceived as especially high-risk LDTs, and in October 2018 the FDA issued a safety communication warning against the use of unapproved LDTs that describe relationships between gene variants and particular drugs (pharmacogenomic tests).
+Added: FDA also regulated LDTs for Covid-19 under its EUA authority and related guidance.
+Added: HHS initially issued a policy in August 2020 stating that FDA could not require premarket review (including EUAs) for LDTs.
+Added: But this HHS policy was revoked in November 2021, reinstating FDA's prior approach for oversight of Covid-19 LDTs.
+Added: Thus, while FDA generally exercises enforcement discretion for LDTs it continues to exercise oversight over certain high-risk tests.
+Added: In addition, over the past several years, several bills to impose a new FDA regulatory framework with similarities to the current medical device framework for “in vitro clinical tests,” which would include both in vitro diagnostics and LDTs, have been introduced.
+Added: We cannot predict the ultimate timing or form of any such legislation or future FDA guidance or regulation or their potential impact.
+Added: Any new regulatory approach for LDTs by the FDA, whether through legislation or regulation, would likely lead to an increased regulatory burden, including additional costs and delays in introducing new tests.
+Added: While the ultimate impact of any changes to the FDA’s current approach is unknown, it may be extensive and may result in significant change.
In addition, some states require that any laboratory be licensed by the appropriate state agency in the state in which it operates.
−Removed: Laboratories must also hold state licenses or permits, as applicable, from various states including, but not limited to, California, Florida, New York, Pennsylvania, Rhode Island and Maryland, to the extent that they accept specimens from one or more of these states, each of which requires out-of-state laboratories to obtain licensure.
+Added: Laboratories must also hold state licenses or permits, as applicable, from various states including, but not limited to, California, New York, Pennsylvania, Rhode Island and Maryland, to the extent that they accept specimens from one or more of these states, each of which requires out-of-state laboratories to obtain licensure.
If a laboratory is out of compliance with state laws or regulations governing licensed laboratories or with CLIA, it may be subject to enforcement actions that may include suspension, limitation or revocation of the license or CLIA certificate, assessment of financial penalties or fines, or imprisonment.
Loss of a laboratory’s CLIA certificate or state license may also result in the inability to receive payments from state and federal health care programs as well as private third-party payors.
−Removed: If, in the future, we perform clinical diagnostic testing, we would also become subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as additional federal and state laws that impose a variety of fraud and abuse prohibitions on healthcare providers, including clinical laboratories.
+Added: When we perform clinical diagnostic testing, we are subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as additional federal and state laws that impose a variety of fraud and abuse prohibitions on healthcare providers, including clinical laboratories.
Europe/Rest of World Government Regulation
3 unchanged sentences
and may be easier or more difficult to satisfy and are subject to change.
−Removed: For example, the European Union (the EU) recently published new regulations that will result in greater regulation of medical devices and IVDs.
−Removed: This new IVD regulation (new IVD Regulation) is significantly different from the European directive for In vitro diagnostic products (IVD Directive) that it replaces in that it will ensure that the new requirements apply uniformly and on the same schedule across the member states, include a risk-based classification system and increase the requirements for conformity assessment.
−Removed: The CE registration for Uman’s Nf-L ELISA assay kit was approved in March 2014 under the IVD Directive .
−Removed: Under the IVD Directive the assay is classified as a general IVD product, class I and required self-certification with no involvement of a notified body/authority.
−Removed: Under the new IVD Regulation, the requirements increase and involve assessment by a notified body for class B, C and D products.
−Removed: Uman’s Nf-L ELISA assay kit is classified as class B product and must fully implement the new IVD Regulation by May 2027.
−Removed: The new requirements include an ISO 13485 certification of the quality system (which Uman received July 2018) and increased technical evidence and follow-up of performance of the specific product (e.g., clinical evidence and post-market activities).
−Removed: The work to meet the new technical requirements is on-going.
−Removed: An internal GAP-analysis is to be performed and work to eliminate the GAPs performed.
−Removed: When completed, the available technical documentation will be assessed by an external consultant.
+Added: For example, in the European Union (the E.U.) new regulations recently entered into force that introduce greater regulation of medical devices and IVDs.
+Added: The new IVD regulation (the IVD Regulation) is significantly different from the European directive for IVD medical devices (the IVD Directive) that it replaces in that it ensures that the new requirements apply uniformly and on the same schedule across the member states, includes a risk-based classification system and increases the requirements for conformity assessment.
+Added: The CE registration for the Nf-L ELISA assay kit of our subsidiary Uman was approved in March 2014 under the IVD Directive .
+Added: Under the IVD Directive, the assay is classified as a general IVD product and required self-certification with no involvement of a notified body/authority.
+Added: The IVD Regulation introduces a new classification system for IVDs and assessment by a notified body is required for class B, C and D products.
+Added: Uman’s Nf-L ELISA assay kit is classified as a class B product and must fully comply with (and have a CE mark issued under) the IVD Regulation by May 2027.
+Added: The new requirements include an ISO 13485 certification of the quality system (which Uman received in July 2018) and increased technical evidence and follow-up of performance of the specific product (e.g., clinical evidence and post-market activities).
+Added: The work to evaluate and to meet the new technical requirements is on-going.
When all requirements are met, a notified body will be contacted, and the certification initiated.
+Added: The NF-light Serum ELISA is currently sold only as a RUO product (not intended for diagnostic use).
+Added: Work is on-going to prepare a technical file compliant with the IVD Regulation for this product as well.
Other Governmental Regulation
−Removed: Data Privacy and Security Laws and Regulations
−Removed: As a business with a global footprint, compliance with evolving regulations and standards in data privacy and cybersecurity has resulted, and may continue to result, in increased costs, new compliance challenges, and the threat of increased regulatory enforcement activity.
+Added: Privacy and Data Security Laws and Regulations
+Added: As a business with a global footprint, compliance with evolving regulations and standards in privacy and data security has resulted, and may continue to result, in increased costs, new compliance challenges, and the threat of increased regulatory enforcement activity.
Our business relies on the secure electronic transmission, storage and hosting of sensitive information, including personal information, protected health information, financial information, intellectual property and other sensitive information related to our customers and workforce.
For example, in the U.S., the collection, maintenance, protection, use, transmission, disclosure and disposal of certain personal information and the security of medical devices are regulated at the U.S.
−Removed: federal and state, international
−Removed: and industry levels.
+Added: federal and state, international and industry levels.
federal and state laws protect the confidentiality of certain patient health information, including patient medical records, and restrict the use and disclosure of patient health information by health care providers.
−Removed: Privacy and Security Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), govern the use, disclosure, and security of protected health information by “Covered Entities,” (which are health care providers that submit electronic claims, health plans, and health care clearinghouses) and by their “Business Associates” (which is anyone that performs a service on behalf of a Covered Entity involving the use or disclosure of protected health information and is not a member of the Covered Entity’s workforce).
+Added: Privacy and Security Rules under HIPAA, as amended, and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), govern the use, disclosure, and security of protected health information by “Covered Entities,” (which are health care providers that submit electronic claims, health plans, and health care clearinghouses) and by their “Business Associates” (which is anyone that performs a service on behalf of a Covered Entity involving the use or disclosure of protected health information and is not a member of the Covered Entity’s workforce).
Rules under HIPAA and HITECH include specific security standards and breach notification requirements.
−Removed: Department of Health and Human Services (HHS) (through the Office of Civil Rights) has direct enforcement authority against Covered Entities and Business Associates with regard to both the Security and Privacy Rules, including civil and criminal liability.
+Added: HHS (through the Office of Civil Rights) has direct civil enforcement authority against Covered Entities and Business Associates with regard to both the Security and Privacy Rules.
+Added: Department of Justice has criminal enforcement authority against Covered Entities, Business Associates, and certain other entities and individuals.
+Added: In addition, State Attorneys General may being enforcement actions under HIPAA.
Generally Quanterix is not a Covered Entity, however, we may operate as a Business Associate to Covered Entities under certain circumstances.
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privacy and data protection rules.
−Removed: Because the laws and regulations continue to expand, differ from jurisdiction to jurisdiction, and are subject to evolving (and at times inconsistent) governmental interpretation, compliance with these laws and regulations may require significant additional cost expenditures or changes in products or business that increase competition or reduce revenue.
+Added: Because the laws and regulations continue to expand, differ from jurisdiction to jurisdiction, and are subject to evolving (and at times inconsistent) governmental interpretation, compliance with these laws and regulations may require significant additional expenditures or changes in products or business that increase competition or reduce revenue.
Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities.
Environmental Health and Safety Laws
−Removed: We are subject to laws and regulations related to the protection of the environment, the health and safety of employees and the handling, transportation and disposal of medical specimens, infectious and hazardous waste and radioactive materials.
+Added: We are subject to federal, state, and local laws and regulations related to the protection of the environment, the health and safety of employees and the handling, transportation, storage and disposal of medical specimens, infectious and hazardous waste and radioactive materials.
For example, the U.S.
1 unchanged sentence
This includes requirements to develop and implement multi-faceted programs to protect workers from exposure to blood-borne pathogens, including preventing or minimizing any exposure through needle stick injuries.
+Added: OSHA also regulates the use of hazardous chemicals in the workplace.
+Added: Likewise, we are subject to EPA and state requirements relating to the management and disposal of hazardous waste, and state requirements relating to the disposal of regulated medical waste.
For purposes of transportation, some biological materials and laboratory supplies are classified as hazardous materials and are subject to regulation by one or more of the following agencies:
4 unchanged sentences
As of December 31, 2022, we had 370 full-time employees, of which 125 work in sales, sales support, field service, and marketing, 85 work in engineering and research and development, 104 work in manufacturing and operations and 56 work in general and administration.
−Removed: Of our 460 full-time employees, 407 were located in the United States and 53 were located in twelve foreign countries.
+Added: Of our 370 full-time employees, 309 were located in the United States and 61 were located in 11 foreign countries.
None of our employees are represented by a labor union or subject to a collective bargaining agreement.
−Removed: We have a unique culture that stresses the impact our work has on the eradication of human diseases including Alzheimer’s, cancer and COVID-19.
+Added: We have a unique culture that stresses the impact our work has on the eradication of human diseases.
We invest in creating a diverse, inclusive and safe work environment where our employees can deliver their workplace best every day.
−Removed: Historically, we have experienced a turnover rate that is comparable to industry average.
Our success depends upon our ability to attract and retain highly qualified management and technical employees.
−Removed: Talent management is critical to our ability to execute our long-term growth strategy, including providing career growth, on-the-job learning opportunities and competitive compensation.
+Added: Talent management is critical to our ability to execute our long-term growth strategy, and we seek to cultivate a superior pool of talent by providing career growth, on-the-job learning opportunities and competitive compensation.
We are committed to an inclusive culture which values equality, opportunity and respect.
1 unchanged sentence
As of December 31, 2022, approximately 44% of our employees were women and approximately 36% were non-white.
−Removed: We are focused on the engagement and empowerment of our employees through the demonstration of our foundational values, which we refer to as AT&T3:
−Removed: Accountability, Trust, Teamwork and Transparency.
Workforce Compensation and Pay Equity
9 unchanged sentences
Accordingly, we are committed to the health, safety and wellness of our employees and contractors.
−Removed: We provide our employees with a wide range of benefits, including benefits directed to their health, safety and long-term financial security.
−Removed: In response to the COVID-19 pandemic, we have implemented significant changes that we determined were in the best interest of our employees, as well as the communities in which we operate, and which comply with government regulations.
−Removed: This includes allowing our employees to work remotely as appropriate, while implementing significant safety measures designed to protect the health of all those working in and entering our facilities.
+Added: We provide our
+Added: employees with a wide range of benefits, including benefits directed to their health, safety and long-term financial security.
Corporate Information
7 unchanged sentences
We also make available, free of charge on our website, the reports filed with the SEC by our executive officers, directors and 10% stockholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those persons.
−Removed: You can also review our electronically filed reports and other information that we file with the SEC on the SEC’s website at http://www.sec.gov .
+Added: Our electronically filed reports and other information that we file with the SEC can be viewed on the SEC’s website at http://www.sec.gov .
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.