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Our platforms are based on our proprietary digital “Simoa” detection technology.
−Removed: Our Simoa bead-based and planar array platforms enable customers to reliably detect protein biomarkers in extremely low concentrations in blood, serum and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies, and also allow researchers to define and validate the function of novel protein biomarkers that are only present in very low concentrations and have been discovered using technologies such as mass spectrometry.
+Added: Our Simoa bead-based and planar array platforms enable customers to reliably detect protein biomarkers in extremely low concentrations in blood, serum and other fluids that, in many cases, are undetectable using conventional, analog immunoassay technologies, and also allow researchers to define and validate the function of novel protein biomarkers that are only present in very low concentrations.
These capabilities provide our customers with insight into the role of protein biomarkers in human health that has not been possible with other existing technologies and enable researchers to unlock unique insights into the continuum between health and disease.
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 are currently focusing on protein detection, which we believe is an area of significant unmet need and where we have significant competitive advantages.
−Removed: However, in addition to enabling new applications and insights in protein analysis, our Simoa platforms have also demonstrated applicability across other testing applications, including detection of nucleic acids and small molecules.
−Removed: We believe that our Simoa platforms are 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.
+Added: 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.
+Added: Furthermore, we believe the HD-X is the most sensitive commercially available automated multiplex protein detection platform .
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, approximately 10,500 of which are known to be secreted in blood.
−Removed: Accordingly, while research on nucleic acids provides valuable information about the role of genes in health and disease, proteins are more prevalent and, we believe, more relevant to a precise understanding of the nuanced continuum between health and disease.
−Removed: Protein measurement goes beyond genetic predisposition, reflecting the impact of a range of influences on health, including environmental factors and lifestyle, providing deeper and more relevant insight into what is happening in a person’s body in real time.
+Added: 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.
Researchers and clinicians rely extensively on protein biomarkers for use as research and clinical tools.
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Our Simoa platforms have achieved significant scientific validation and commercial adoption.
−Removed: Simoa technology has been cited in more than 1,100 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 950 customers across our end markets, and includes all 20 of the 20 largest biopharmaceutical companies.
+Added: 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.
+Added: Our growing customer base is comprised of over 1,120 customers across our end markets and includes 22 of the 25 largest biopharmaceutical companies.
Our Products and Services
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Given our target customers’ familiarity with the core ELISA technology, we believe this offers us a significant competitive advantage.
−Removed: 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
−Removed: analysis and digital readout of each individual molecule, which is not possible with conventional ELISA technology.
+Added: 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.
This ability is the key to our bead-based technology’s unprecedented sensitivity.
−Removed: In January 2018, we acquired Aushon BioSystems, Inc.
+Added: In addition, in January 2018, we acquired Aushon BioSystems, Inc.
(Aushon) and its proprietary sensitive planar array detection technology.
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 following three Simoa instruments, which we believe are the most sensitive multiplex protein detection platforms commercially available today:
+Added: We currently offer the
+Added: 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.
−Removed: The HD-X is an upgraded version of the Simoa HD-1 (which was launched in January 2014) that was designed to deliver significant productivity and operational efficiency improvements, as well as greater user flexibility.
+Added: The HD-X is an upgraded version of the Simoa HD-1 (our first Simoa instrument which was launched in January 2014) that was designed to deliver significant productivity and operational efficiency improvements, as well as greater user flexibility.
The HD-X is based on our bead-based technology, and assays run on the HD-X are fully automated.
−Removed: We believe the full automation of the HD-X provides us with an additional significant competitive advantage with biopharmaceutical customers.
We commercially launched our SR-X instrument in December 2017.
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We commercially launched our SP-X instrument in April 2019.
−Removed: The SP-X is based on our planar array technology, which allows for significantly greater multiplexing capabilities, and is, we believe, ideal for oncology and immunology applications.
+Added: The SP-X is based on our Simoa planar array technology, which allows for significantly greater multiplexing capabilities, and is, we believe, ideal for oncology and immunology applications.
The current menu of approximately 80 analyte-specific single-plex and multi-plex bead-based assay kits includes assays for biomarkers in the areas of neurology, infectious disease, immunology, oncology and cardiology for both human and mouse samples.
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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 addition, 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: Nf-L has seen a dramatic growth as a neurological biomarker in the last three years since we developed the first assay that could reliably measure Nf-L in blood using Uman’s antibodies and our Simoa technology.
−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 brain biomarkers available today.
−Removed: Despite significant efforts by us and others to identify or develop an alternative source of antibodies, the Uman Nf-L antibodies remain the best-in-class for highly sensitive and specific Nf-L detection in serum or plasma.
−Removed: The following graphic depicts the sensitivity of the Uman antibodies to detect Nf-L in blood and CSF compared to over a dozen other antibody pairs tested by Quanterix:
−Removed: The superiority of the Uman antibodies is further evidenced by the fact that, to date, in over 380 publications relating to the detection of Nf-L in serum or plasma, 100% used the Uman antibodies.
−Removed: The Uman acquisition secures the Nf-L antibody supply critical to our industry leading ultrasensitive Simoa Nf-L assays and services, provides us with additional revenue opportunities via the sale of the Nf-L antibodies and Nf-L ELISA kits, and positions us to capitalize on significant growth opportunities with Nf-L applications in Alzheimer’s disease, multiple sclerosis, and other neurodegenerative conditions.
−Removed: In view of the COVID-19 pandemic, in the second quarter of 2020 we adjusted our operations to expand capacity in our Accelerator Laboratory to support customers whose operations have been disrupted and to sustain their clinical trials.
+Added: 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.
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 U.S.
−Removed: Food and Drug Administration (the FDA) issued an Emergency Use Authorization (EUA) for our Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test that is run on our HD-X instrument.
−Removed: This test targets IgG antibodies that are directed against the region of the novel coronavirus known as the spike protein.
−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 (N protein), which is known to be elevated in respiratory fluids during the initial acute phase of the infection.
−Removed: We currently intend to pursue authorization for additional sample types, including nasal swabs, saliva, and capillary dried blood obtained from a fingerstick.
−Removed: Preliminary clinical research studies suggest the viral antigen may be readily detectable in asymptomatic and pre-symptomatic patients, and we are exploring extending the test to screening applications, home-based sample collection and pooling to enable larger scale testing.
+Added: 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.
+Added: 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.
+Added: We are exploring extending the test to home-based sample collection and pooling to enable larger scale testing.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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
+Added: brain biomarkers available today.
+Added: 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.
+Added: 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.
+Added: 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.
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, Uman sells Nf-L antibodies and Nf-L ELISA kits directly, and in conjunction with a distributor worldwide (excluding certain Nordic countries).
+Added: In addition, we sell Uman’s Nf-L antibodies and Nf-L ELISA kits directly, and in conjunction with a distributor worldwide.
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.
Our Market Opportunities
−Removed: Our Simoa platforms have applications across the life science research, diagnostics and precision health screening markets.
−Removed: Our initial target market has been the life science research market, in particular neurology and oncology.
−Removed: According to estimates in the Third-Party Research Report, we believe that our pre-COVID addressable neurology, immunology and oncology life science research market is approximately $1 billion per year.
−Removed: We believe our
−Removed: recent EUA approvals will allow us to expand our life science research market focus into COVID-19, which we estimate has a currently addressable potential of $0.2 billion.
−Removed: 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 addressable market is expected to expand to approximately $7 billion.
−Removed: As our customers continue to gain experience with our proprietary Simoa technology, we believe the opportunity to access markets beyond research, such as diagnostics and precision health screening, will be significant.
−Removed: The Third-Party Research Report also estimates that the diagnostic and precision health screening markets have the potential to reach an aggregate of approximately $55 billion per year, with neurology diagnostics estimated at approximately $18 billion, proteomic liquid biopsy estimated at approximately $20 billion, COVID estimated at approximately $12 billion, and precision health screening estimated at approximately $5 billion.
−Removed: Life Science Research
−Removed: Our initial target market has been the large and growing life science research market.
−Removed: We believe our Simoa platforms are well-positioned to capture a significant share of this market 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, we believe that Simoa is penetrating the existing market for protein analysis and holds potential to significantly grow the life science research market as researchers expand their research into the diseases associated with the thousands of proteins that were previously undetectable.
−Removed: Simoa also enables earlier detection of the proteins that are currently detectable by other technologies only after they have reached levels that reflect more advanced disease or injury.
−Removed: As an indication of the market’s acceptance of our technology, biopharmaceutical researchers are also integrating our platforms into drug development protocols to more efficiently and effectively develop drugs.
−Removed: In addition to enabling new applications and insights in protein analysis, our Simoa bead-based technology can be used to detect other analytes, such as nucleic acids and small molecules, which expands our market opportunity.
−Removed: We believe that this technology has the potential to ultimately provide the same sensitivity as polymerase chain reaction (PCR), which is the most commonly used technology for nucleic acid detection, without the distortion and bias issues associated with amplification used in PCR.
−Removed: We believe the diagnostic market represents a significant commercial opportunity for our Simoa technology as well.
−Removed: We believe existing 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.
−Removed: We also believe that the ultra-sensitive protein detection provided by Simoa can enable the development of a new category of non-invasive diagnostic tests and tools based on blood, serum, saliva 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: 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.
+Added: Life Science Research/Drug Trial Markets
+Added: 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: We have chosen these markets to target initially because we believe there is reduced regulatory and reimbursement risk.
+Added: 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.
+Added: 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.
+Added: 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.
+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: 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.
+Added: 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.
+Added: The diagnostic market represents a significant future commercial opportunity for our Simoa technology as well.
+Added: 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.
Simoa technology also has significant potential in the emerging field of companion diagnostics.
−Removed: Drug developers can use Simoa to stratify patients into categories, enabling selection of those patients for whom a drug is expected to be most effective and safe.
−Removed: Not only does Simoa have the potential to be used to develop companion diagnostics to stratify patients in clinical trials and for treatment, but Simoa’s sensitivity may also enable the development of companion diagnostics based on protein biomarkers that can regularly monitor whether an approved drug is having the desired biological effect, enabling doctors to quickly and efficiently adjust the course of treatment as appropriate.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: In addition, in 2021, our pTau-181 assay was granted Breakthrough Device Designation from the U.S.
+Added: FDA as an aid in the diagnosis of Alzheimer’s disease.
+Added: We believe this gives us an opportunity to further advance a potential Alzheimer’s disease diagnostic test either alone or with a partner.
+Added: 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.
Precision Health Screening
−Removed: The ability of our Simoa platforms to detect and quantify normal physiological levels of proteins in low abundance that are undetectable using conventional, analog immunoassay technologies may 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: 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
−Removed: periodically with baseline measurements to predict or detect the early onset of disease, prior to the appearance of symptoms.
+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, enabling a “precision health” revolution.
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.
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We believe that our competitive strengths include the following:
−Removed: ● Proprietary ultra-sensitive Simoa digital immunoassay technology platforms, that enable researchers and clinicians to obtain information from less invasive procedures in smaller sample sizes.
−Removed: We believe our Simoa platforms are the most sensitive commercially available protein detection platforms, and can detect and quantify proteins of clinical interest that are undetectable using conventional, analog immunoassay technologies.
+Added: ● Proprietary ultra-sensitive Simoa digital immunoassay technology platforms.
+Added: We believe our Simoa platforms are among the most sensitive, commercially available protein detection platforms, and can detect and quantify proteins of clinical interest that are undetectable using conventional, analog immunoassay technologies.
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 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 100-fold .
+Added: 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.
−Removed: Simoa uses the basic principles of conventional bead-based ELISA immunoassay technology.
+Added: Simoa uses the basic principles of conventional bead-based ELISA immunoassay technology, which has been the most widely used method of detection of proteins for over 40 years.
Adding digital capability to this industry standard platform has resulted in expanded capabilities and improved performance.
Given our target customers’ familiarity with the core ELISA technology, our Simoa platforms are easily integrated with existing customer workflows including data analysis.
−Removed: ● Deep and expanding scientific validation.
−Removed: Our Simoa technology has been cited in more than 1,100 scientific publications, 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 950 customers includes some of the world’s leading academic and government research institutions as well as all 20 of the 20 largest biopharmaceutical companies.
+Added: ● Deep and expanding scientific validation and customer base.
+Added: 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.
+Added: 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.
● Leading position in market solidified by robust customization capabilities, assay design flexibility and automation of our HD-X instrument.
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● Highly attractive business model that leverages growing installed base of instruments.
−Removed: 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: The integration of our technology in our customers’ projects also provides ongoing sales of assays and consumables, resulting in a growing revenue stream.
−Removed: consumables revenue increased to $27.4 million in 2020 from $25.6 million in 2019 and $13.8 million in 2018, and represented approximately 32% of our total revenue in 2020.
+Added: Our installed instrument base increased by 32% in 2021 to 708 instruments as of December 31, 2021.
+Added: 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.
+Added: 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.
+Added: Consumables and other product revenue represented approximately 50% of our total revenue in 2021.
● Our highly experienced senior management team.
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Protein measurement goes beyond genetic predisposition, indicating the impact of a range of influences on health, including environmental factors and lifestyle, providing deeper and more relevant insight into what is happening in a person’s body in real time.
−Removed: 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 drug development.
−Removed: ● Continue to drive adoption of our Simoa technology in the life science research market in the near-term, and the diagnostics and precision health screening markets in the long-term.
+Added: 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.
+Added: ● 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.
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 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 recently had two EUAs approved for our COVID assays.
+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
+Added: to help increase the potential of regulatory approval.
+Added: We have focused on these markets because we believe there is reduced regulatory and reimbursement risk for us in these markets.
+Added: 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.
+Added: We have had two EUAs approved for our COVID assays.
+Added: 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.
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 as a biomarker to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
−Removed: The importance of Nf-L as a neuro biomarker has increased significantly since we developed the first assay that could reliably measure Nf-L in blood.
−Removed: This allowed research of neurological disorders, previously limited primarily to CSF, to expand significantly, and many of the world’s foremost neurology researchers and clinicians believe that Nf-L may be one of the most clinically relevant brain biomarkers available today.
−Removed: To capitalize on the growing importance of this biomarker, 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: We believe that this acquisition positions us to capitalize on significant growth opportunities with Nf-L applications in neurodegenerative conditions .
+Added: ● Leverage the growing importance of Nf-L and other neurological biomarkers to advance the development of therapeutics and diagnostics for neurodegenerative conditions.
+Added: 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.
+Added: 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.
+Added: In addition, other neuro biomarkers, such as pTau-217 and pTau-181, have shown increasing relevance in neurological research and drug development.
+Added: 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: 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.
+Added: 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.
+Added: 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.
+Added: We believe that the use of biomarkers in clinical trials for neurological conditions is becoming increasingly important.
+Added: 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.
● Grow into new markets organically with our customers and through strategic collaborations.
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
−Removed: some of the work that our customers are doing today in the research market.
−Removed: For example, Simoa’s unprecedented sensitivity has the potential to uncover research insights that could identify novel biomarkers, which could help stratify patients in clinical trials potentially leading to a companion diagnostic, and ultimately a precision health test that could monitor and identify early disease.
+Added: 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.
+Added: 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.
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.
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 Healthineers to begin developing blood-based Nf-L clinical tests for future commercialization.
−Removed: Additionally, in September 2020, we entered into a Non-exclusive License Agreement (the Abbott License Agreement) with Abbott Laboratories (Abbott), pursuant to which 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 in vitro diagnostics (IVD).
+Added: 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.
+Added: Additionally, in September 2020, we granted Abbott Laboratories a non-exclusive license under our bead-based single molecule detection patents for IVD use.
● Grow through strategic acquisitions.
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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 growing significance of Nf-L as a neurological biomarker.
+Added: 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
+Added: growing significance of Nf-L as a neurological biomarker.
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.
+Added: ● Leverage the PPH ecosystem.
+Added: Powering Precision Health (PPH) is a non-profit organization founded in 2016 by our Chief Executive Officer, Kevin Hrusovsky.
+Added: 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.
+Added: 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.
Industry Background
−Removed: We intend to pursue the application of our Simoa technology to the life science research, diagnostics and precision health screening markets.
−Removed: Our initial commercial strategy targets the large and growing life science research market, 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 up to $62 billion.
+Added: We intend to pursue the application of our Simoa technology to the life science research/drug trial, diagnostics and precision health screening markets.
+Added: 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.
+Added: 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.
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, approximately 10,500 of which 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 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.
Accordingly, the study of much of the proteome has not been practical given the limited level of sensitivity of existing technologies.
−Removed: To date, across our platforms, we have commercialized assays that address approximately 178 protein biomarkers secreted or released in blood and CSF.
+Added: Currently, across our platforms, we commercialize assays that address approximately 154 protein biomarkers secreted or released in blood and CSF.
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
−Removed: into what is happening in a patient’s body in real time.
+Added: 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.
For example, identical twins have the same genotype, but may develop different diseases over the course of their lifetime, largely due to environmental factors.
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 individuals.
+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
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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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 what is estimated to be approximately 10,500 secreted proteins in circulation in human blood.
+Added: 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.
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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Genomic Analysis
−Removed: Over the past few decades, scientists have developed a variety of genomic analysis methods to measure an increasing number of genomic biomarkers aimed at more effectively detecting diseases.
+Added: Over the past few decades, scientists have developed a variety of genomic analysis methods to measure an increasing number of genomic biomarkers aimed at detecting diseases.
The most widely used method for genetic testing is PCR, which involves amplifying, or generating billions of copies of, the DNA sequence in question and then detecting the DNA with the use of fluorescent dyes.
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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.
−Removed: We have published an approach to increase the sensitivity of our Simoa technology 100-fold.
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 achieved with our Simoa bead-based technology by using beads labeled with different fluorescent dyes specific to the biomarker being analyzed.
+Added: Multiplexing is
+Added: 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: 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 may be 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.
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: Whereas other assay technologies
−Removed: 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 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.
+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, 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: In the first quarter of 2020, we launched a new Simoa 6-plex human cytokine Simoa bead-based assay for the HD-X and SR-X instrument platforms.
−Removed: This assay is the only commercially available product supporting quantitative multiplex measurement of six key immunomodulatory cytokines (IFNg, IL-6, IL-10, IL-12p70, IL-17A and TNFa) at baseline levels in both normal healthy individuals and patient cohorts in therapeutic areas spanning cancer, autoimmune disease, neurodegeneration and infectious disease.
+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 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: 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.
+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 two years.
Simoa Planar Array Technology
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Nucleic acid detection probes (instead of detection antibodies) are then added and attach to the target nucleic acid molecules which are then labeled using an enzyme substrate that is detected and counted using the Simoa disk and instrument.
−Removed: This assay is pictured below:
−Removed: Simoa has been used to detect short sequences of RNA, known as microRNA, that are important in a number of biological systems, and are widely used in innovative therapeutic and gene editing technologies.
−Removed: For example, the assay was used to detect microRNA-122 (miR-122), a marker of liver toxicity, from the serum of patients who had overdosed
−Removed: with acetaminophen.
−Removed: As shown in the graph below, these patients had elevated miR-122 levels compared to healthy controls.
−Removed: This approach suggests potential for applications for measuring drug-induced liver injury for both safety testing of drugs in development and for monitoring of approved drugs.
Our Market Opportunities
−Removed: Our commercial strategy is to pursue the application of our Simoa technology to the life science research, diagnostics and precision health screening markets.
−Removed: Life Science Research
−Removed: Our initial target market is the large and growing life science research market.
−Removed: We believe our Simoa platforms are well-positioned to capture a significant share of this market because of superior sensitivity, automated workflow capabilities, multiplexing and the ability to work with a broader range of sample types.
+Added: 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.
+Added: Life Science Research/Drug Trial Markets
+Added: 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: We have chosen these markets to target initially because of the reduced regulatory and reimbursement risk.
+Added: 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.
Proteomics, the study of the proteins produced by the body, is important to understanding disease, and researchers study proteins to understand the biological basis for disease and how to improve diagnosis and treatment.
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Simoa technology provides researchers the ability to see the nuanced continuum of health to disease more efficiently and effectively than any other technology commercially available today, offering the potential for the first time to better understand the onset of disease cascades and catalyzing a new era of medical and life science research, drug discovery and disease prevention.
−Removed: As an indication of the market’s acceptance of our Simoa technology, researchers at pharmaceutical and biotechnology companies are integrating our platforms into drug development protocols to more efficiently and effectively develop drugs.
+Added: 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.
+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.
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: We estimate that our Simoa technology has been utilized in projects for over 800 clinical trials to date.
−Removed: According to estimates in the Third-Party Research Report, we believe that our pre-COVID addressable neurology, immunology and oncology life science research market was approximately $1 billion per year.
−Removed: Our recent EUA approvals expand our life science research market focus into COVID-19, which we estimate has currently addressable potential of $0.2 billion.
−Removed: 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 addressable market is expected to expand to approximately $7 billion.
+Added: 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.
The diagnostic market represents a significant future commercial opportunity for our Simoa technology as well.
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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: For example, researchers have conducted studies using Simoa that indicate that neurological biomarkers, including tau and Nf-L, may someday be able to replace diagnostic imaging to diagnose traumatic brain injury (TBI).
−Removed: Our Simoa assays for tau and Nf-L are 3,500-fold and 840-fold more sensitive, respectively, than conventional ELISA technologies.
−Removed: Almost 90% of patients who visit U.S.
−Removed: hospital emergency rooms and receive a computerized tomography (CT) scan show no structural brain injury.
−Removed: In addition, CT scans have approximately 100 times more radiation than a chest x-ray, and are suspected of causing cancer in up to 29,000 people per year, underscoring the need for development of a safe and accurate blood-based diagnostic test for TBI, which we believe may be enabled by our Simoa technology.
Simoa technology also has significant potential in the emerging field of companion diagnostics.
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 to study for whom a drug is expected to be most effective and safe.
+Added: 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.
Companion diagnostics have demonstrated the ability to both improve the probability of approval and accelerate approval of new drugs.
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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: There has been significant interest from third parties to use our technology to develop applications for the diagnostic market.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: We are exploring extending the test to home-based sample collection and pooling to enable larger scale testing.
+Added: In 2021, our pTau-181 assay was granted Breakthrough Device designation from the FDA as an aid in the diagnosis of Alzheimer’s disease.
+Added: We believe this gives us an opportunity to further advance a potential Alzheimer’s disease diagnostic test either alone or with a partner.
+Added: There has also been significant interest from third parties to use our technology to develop applications for the diagnostic market.
+Added: 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: 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.
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.
+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
+Added: used to monitor protein biomarker levels of seemingly healthy, asymptomatic people, and potentially to signal and provide earlier detection of the onset of disease.
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.
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.
−Removed: The Third-Party Research Report estimates that the diagnostic and precision health screening markets have the potential to reach an aggregate of approximately $55 billion per year, with neurology diagnostics estimated at
−Removed: approximately $18 billion, proteomic liquid biopsy estimated at approximately $20 billion, COVID estimated at approximately $12 billion, and precision health screening estimated at approximately $5 billion, which would be addressable upon receipt of any required regulatory approvals.
Our Key Focus Areas
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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 injuries and diseases are diagnosed and treated.
+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 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.
To our knowledge, the brain is the only organ in the body for which there is not currently a blood-based diagnostic test.
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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 these neural biomarkers in the blood are so low that they are undetectable by conventional, analog immunoassay technologies.
−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: 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.
−Removed: This is a significant advantage in terms of ease of use, patient comfort, speed and cost-effectiveness.
−Removed: To date, there have been over 670 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 multiple sclerosis, Alzheimer’s disease, dementia, Parkinson’s disease, and TBI.
+Added: However, the concentrations of many these neural biomarkers in the blood are so low that they are undetectable by conventional, analog immunoassay technologies.
+Added: 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.
The goal of this research is to eventually develop accurate diagnostic tools, predictive health screens and, ultimately, more effective treatments.
−Removed: Evidence of the potential clinical utility of Nf-L as a biomarker in neurological disease is progressing rapidly, in particular with respect to multiple sclerosis.
−Removed: At the 35 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September 2019, there were nearly 50 presentations in which our Simoa Nf-L assay was used.
−Removed: In one 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.
−Removed: In another ECTRIMS presentation, Roche presented retrospective data from its Phase III OPERA I, OPERA, II AND ORATORIO trials of its approved multiple sclerosis drug OCREVUS (ocrelizumab).
−Removed: OCREVUS was only approved in 2017, but it has already become the multiple sclerosis market leader in its class, recording sales of $1.72 billion in the first half of 2019.
−Removed: By 2025, annual sales of the drug are estimated to reach $6.8 billion.
−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.
−Removed: In an article published by Bjornevik et al 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 MS 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 2017, researchers using Simoa technology published a paper in JAMA Neurology demonstrating that a simple blood test for the neurological biomarker Nf-L exhibited the same level of diagnostic accuracy for diagnosing Alzheimer’s disease as currently established CSF biomarkers.
+Added: The importance of Nf-L and other neurological biomarkers, such as pTau-181 and pTau-217, has increased significantly in recent years.
+Added: 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.
+Added: 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 is a collective name for brain syndromes that affect memory, thinking, behavior and emotion.
+Added: According to Alzheimer’s Disease International , as of 2021, there were more than 55 million people worldwide living with dementia, a figure expected to increase to over 139 million by 2050, and the annual global cost of dementia is now above $1.3 trillion.
+Added: Alzheimer’s disease is a progressive neurodegenerative disorder that affects cognition, function and behavior and is the most common cause of dementia.
+Added: 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: 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: 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.
+Added: 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.
+Added: 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.
+Added: 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.
The study was a major study of almost 600 patients from the Alzheimer’s Disease Neuroimaging Initiative.
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These data suggest a simple Simoa blood test for Nf-L may have clinical utility as a noninvasive biomarker in Alzheimer’s disease.
+Added: 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.
+Added: 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 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.
+Added: The program is designed to enable accelerated development, assessment and review processes, with the intention to provide patients with more timely access to breakthrough technologies or devices.
+Added: 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: Multiple sclerosis is a chronic disease affecting the central nervous system (the brain and spinal cord).
+Added: Multiple sclerosis occurs when the immune system attacks nerve fibers and myelin sheathing (a fatty substance which surrounds/insulates healthy nerve fibers) in the brain and spinal cord.
+Added: This attack causes inflammation, which destroys nerve cell processes and myelin, altering electrical messages in the brain.
+Added: Multiple sclerosis is unpredictable and affects each patient differently – some individuals may be mildly affected, while others may lose their ability to write, speak or walk.
+Added: According to the National MS Society, more than 2.3 million people have a diagnosis of multiple sclerosis globally.
+Added: 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.
+Added: 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: In 2021, Simoa technology supported 31 scientific presentations at the 37 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 .
+Added: 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: 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.
+Added: One of the secondary endpoints included serum levels of Nf-L as measured using our Simoa Nf-L 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 Nf-L, compared to those in the comparator arm of teriflunomide treated patients.
+Added: 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).
+Added: 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.
+Added: 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 an article published by Bjornevik, et al.
+Added: 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.
+Added: 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.
+Added: 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: 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.
+Added: military, 955 of whom were diagnosed with multiple sclerosis during their period of service.
+Added: 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.
+Added: 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.
TBIs lead to approximately five million individuals visiting emergency rooms per year in the United States alone, often with broad and inconclusive diagnosis.
34 unchanged sentences
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 the second quarter of 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.
+Added: 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.
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.
10 unchanged sentences
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: We currently intend to pursue authorization for additional sample types, including nasal swabs, saliva, and capillary dried blood obtained from a fingerstick.
−Removed: Preliminary clinical research studies suggest the viral antigen may be readily detectable in asymptomatic and pre-symptomatic patients, and we are exploring extending the test to screening applications, home-based sample collection and pooling to enable larger scale testing.
+Added: 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.
+Added: 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.
1 unchanged sentence
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 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
+Added: 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.
27 unchanged sentences
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.
−Removed: We will continue to develop Simoa assays for pathogenic antigens that are competitive in sensitivity to PCR but more specific to the pathogenicity of the offending organism.
−Removed: We believe that these Simoa assays could also be invaluable tools for the development of anti-infective drugs and treatment monitoring of anti-viral and anti-bacterial drugs.
Our Products and Services
−Removed: Our Quanterix commercial portfolio includes research use only (ROU) instruments, assay kits and other consumables, and contract research services offered through our Accelerator Laboratory, as follows:
+Added: Our Quanterix commercial portfolio includes research use only (RUO) instruments, assay kits and other consumables, and contract research services offered through our Accelerator Laboratory, as follows:
Key attributes
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Nf-L capture/detection antibodies with unparalleled sensitivity and specificity
−Removed: Nf-L ELISA kits for CSF;
−Removed: CE-certified in Europe;
+Added: Nf-L ELISA kits for CSF (CE-certified in Europe;
RUO outside of Europe)
+Added: Nf-L ELISA kits for serum (RUO)
licensing and supply arrangement with Siemens Healthineers that will allow Siemens to begin developing blood-based Nf-L clinical tests for future commercialization
8 unchanged sentences
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.
−Removed: sample in to result out), and results for up to 66 samples are available in approximately one hour.
−Removed: We believe that this automation provides us an additional significant competitive advantage with pharmaceutical and biotechnology customers.
+Added: 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.
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.
3 unchanged sentences
Data reduction software automatically converts those signals to concentrations for the different biological molecules.
−Removed: Following commercial launch of the HD-X, we initiated a trade-in program for installed HD-1 instruments that has been exceeding expectations.
−Removed: By the end of 2020, approximately 48% of the HD installed base was HD-X instruments.
+Added: By the end of 2021, approximately 68% of the HD installed base were HD-X instruments.
We commercially launched the SR-X instrument in the fourth quarter of 2017.
13 unchanged sentences
The current menu of approximately 80 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 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
+Added: planar array instrument includes approximately 120 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.
6 unchanged sentences
In August 2019, we completed our acquisition of Uman.
−Removed: Uman supplies neurofilament light (Nf-L) antibodies and ELISA kits for Nf-L detection in CSF.
−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: 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.
+Added: Uman supplies Nf-L antibodies and ELISA kits for Nf-L detection.
+Added: 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.
+Added: 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.
Through our Accelerator Laboratory, which includes a CLIA-certified laboratory, we provide customers a contract research option.
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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 have published an approach to increase the sensitivity of our Simoa technology 100-fold .
+Added: 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 .
We are also focused on expanding our assay menu to extend the scope of applications for our platform and grow our customer base.
−Removed: 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
−Removed: marketing team.
+Added: 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.
We also intend to continue to develop and market new instruments with different and/or improved capabilities in order to further broaden our market reach.
Sales and Marketing
−Removed: 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, Israel, Japan, Lebanon, Mexico, Qatar, Saudi Arabia, Singapore, South Korea and Taiwan.
−Removed: In addition, Uman sells Nf-L antibodies and Nf-L ELISA kits directly, and in conjunction with a distributor worldwide (excluding certain Nordic countries).
+Added: 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.
+Added: In addition, we sell Uman’s Nf-L antibodies and Nf-L ELISA kits directly, and in conjunction with a distributor worldwide.
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.
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, 2020, we had approximately 118 people employed in sales, sales support and marketing, including technical field application scientists and field service personnel.
+Added: 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.
This staff is primarily located in North America and Europe.
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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: To develop a thought leadership position in the precision health arena, we have been a Platinum Sponsor of the annual Powering Precision Health (PPH) Summit since 2016.
−Removed: PPH is an organization founded in 2016 by our President and Chief Executive Officer, Kevin Hrusovsky, that aims to gather many of the world’s top innovators, scientists, physicians, medical professionals, patient advocates, government officials, regulators and investors to debate and collaborate around crucial issues from neurology, oncology and cardiology to inflammation and infectious disease.
−Removed: We believe that sponsoring this event provides Quanterix significant marketing benefits.
Our systems are relatively new to the life science marketplace and require a capital investment by our customers.
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We believe this manufacturing strategy is efficient and conserves capital.
−Removed: However, in the event it becomes necessary to utilize a different contract manufacturer for the HD-X or the SR-X, we would experience additional costs, delays and difficulties in doing so, and our business would be harmed.
+Added: However, in the event it becomes necessary to utilize a different contract manufacturer for the HD-X or the SR-X, we would experience additional costs, delays and difficulties in doing so, and our business could be harmed.
The SP-X instruments are manufactured, tested, shipped and supported by us from our Billerica, Massachusetts facility.
2 unchanged sentences
Although we believe that alternatives would be available, it would take time to identify and validate replacement components, which could negatively affect our ability to supply instruments on a timely basis.
−Removed: To mitigate this risk, we typically carry significant inventory of critical components.
We assemble our assay kits for our bead-based platform in our Billerica, Massachusetts facility.
4 unchanged sentences
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.
−Removed: This agreement provides for a sufficient notification period to allow for supply continuity and the identification and tech transfer to a new supplier in the event either party wishes to terminate the relationship.
+Added: We believe that this agreement provides for a sufficient notification period to allow for supply continuity and the identification and tech transfer to a new supplier in the event either party wishes to terminate the relationship.
Our cuvettes for our bead-based platform are single sourced through STRATEC Biomedical, and the disposable tips used in our bead-based platform are commercially available.
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We agreed to purchase a certain number of instruments in the seven years following the acceptance of the first validation instrument.
−Removed: The STRATEC Supply Agreement was amended in November 2016 to reduce the number of HD instruments we are committed to procure from STRATEC, and this commitment has been met.
+Added: The STRATEC Supply Agreement was amended in November 2016 to reduce the number of HD instruments we were committed to procure from STRATEC, and this commitment has been met.
The instrument price stipulated in the STRATEC Supply Agreement was established based on certain specified assumptions and is subject to certain adjustments.
27 unchanged sentences
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 $18.2 million, is intended to accelerate the continued development, scale-up and deployment of our novel SARS-CoV-2 antigen test.
+Added: 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.
Initial early feasibility of this test was funded in part through the RADx workplan 1 award (WP1) we were granted in June 2020.
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 is subject to achievement of pre-defined milestones and the contract period runs through September 2021.
−Removed: We compete with both established and development-stage life science companies that design, manufacture and market instruments for protein detection, nucleic acid detection and additional applications.
−Removed: For example, companies such as Bio-Techne, Luminex, MesoScale Discovery, Gyros, Nanostring, and others, have products for protein detection
−Removed: that compete in certain segments of the market in which we sell our products.
+Added: 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.
+Added: As of December 31, 2021, we had received $17.7 million out of the full $18.2 million under WP2.
+Added: 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.
+Added: 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.
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.
25 unchanged sentences
The third layer protects novel instrumentation, consumables, and manufacturing processes used in applying the invention to certain commercial products or future product opportunities.
−Removed: The fourth layer is concerned with specific uses of the core
−Removed: technology (e.g., biomarkers and diagnostics).
+Added: The fourth layer is concerned with specific uses of the core technology (e.g., biomarkers and diagnostics).
Our patent strategy is both offensive and defensive in nature;
6 unchanged sentences
A first patent family licensed from Tufts is directed to methods for detecting single molecules.
−Removed: This patent family includes six granted U.S.
+Added: This patent family includes seven granted U.S.
patents, one pending U.S.
7 unchanged sentences
patent in this family is August 22, 2025.
−Removed: A third patent family licensed from Tufts is directed to methods for analyzing analytes using a sensor system with cross-reactive elements.
−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 March 14, 2021.
−Removed: A fourth patent family licensed from Tufts is directed to electro-optical systems including an array and a plurality of electrodes.
+Added: A third patent family licensed from Tufts is directed to electro-optical systems including an array and a plurality of electrodes.
This patent family includes one granted U.S.
1 unchanged sentence
patent in this family is February 14, 2023.
−Removed: A fifth patent family licensed from Tufts is directed to methods for detecting short nucleic acids.
+Added: A fourth patent family licensed from Tufts is directed to methods for detecting short nucleic acids.
This patent family includes one pending U.S.
4 unchanged sentences
patents and 17 pending U.S.
−Removed: patent applications, eight granted European patents and three pending European patent applications, nine granted Japanese patents, four granted Chinese patents and one pending Chinese patent application, five granted Canadian patents and one pending Canadian patent application, one granted Australian patent, and two registered Hong Kong patent applications.
+Added: 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.
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.
1 unchanged sentence
patents and two pending U.S.
−Removed: patent applications, two granted European patent (nationalized and active in eight countries) and one pending European application, two granted Japanese patents, two granted Chinese patents, and one granted Canadian patent.
+Added: patent applications, three granted European patents (nationalized and active in eight countries) and one pending European application, two granted Japanese patents, two granted Chinese patents, and one granted Canadian patent.
The standard patent expiration date for the U.S.
2 unchanged sentences
A second patent family owned by us is directed to methods and systems for determining a measure of the concentration of analyte molecules or particles in a fluid sample, and in particular to methods or systems for determining concentration based on either counting or measured intensity (extending the dynamic range).
−Removed: This patent family includes four granted U.S.
+Added: This patent family includes five granted U.S.
patents and one pending U.S.
3 unchanged sentences
patents is March 1, 2031.
−Removed: A third 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 with or without
−Removed: dissociation.
+Added: A third 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 with or without dissociation.
This patent family includes two granted U.S.
6 unchanged sentences
A fifth patent family owned by us is directed to instruments and consumables.
−Removed: This patent family includes one granted U.S.
−Removed: patent and one pending U.S.
+Added: This patent family includes two granted U.S.
+Added: patents and one pending U.S.
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.
3 unchanged sentences
A sixth patent family owned by us is directed to methods and materials for covalently associating a molecular species with a surface.
−Removed: This patent family includes two pending U.S.
−Removed: patent applications.
+Added: This patent family includes one pending U.S.
+Added: patent application.
The standard patent expiration date for any U.S.
10 unchanged sentences
patents that may issue from this family is September 20, 2038.
−Removed: We own or co-own nine patent families directed to the measurement of particular types of analytes, including prostate specific antigen (PSA), β-amyloid peptide, tau protein, toxin B of C.
−Removed: difficile , neurofilament light, glial fibrillary acidic protein, ubiquitin carboxyl-terminal hydrolase L1, and DNA or RNA molecules.
+Added: 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.
+Added: This patent family includes one pending Patent Cooperation Treaty patent application.
+Added: 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.
+Added: 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: 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.
These families include one granted U.S.
2 unchanged sentences
With the acquisition of Aushon in January 2017, we acquired their patent portfolio for our planar array technology.
−Removed: As of February 1, 2021, the acquired patent portfolio includes at least nine issued U.S.
+Added: As of February 1, 2022, the acquired patent portfolio includes at least ten issued U.S.
patents and one pending U.S.
−Removed: patent application, one granted Australian patent, three granted Canadian patents, four granted European patents (each nationalized and active in between eight and 14 countries) and one pending European patent application, three granted Japanese patents, and one registered Hong Kong patent.
+Added: 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.
We have licensed additional patents and patent applications from third parties.
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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 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: 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
+Added: 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.
We also are not promoting or using our products in the development or promotion of laboratory developed test (LDT) services.
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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 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: If the manufacturer seeks
+Added: 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.
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.
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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
−Removed: guidance with policy specific to development of IVD tests during the COVID-19 public health emergency.
+Added: 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.
This guidance was updated on March 16, 2020, May 4, 2020, and May 11, 2020.
6 unchanged sentences
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: Breakthrough Device Designation
+Added: FDA Breakthrough Device de signation is granted to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
+Added: The goal is to give patients and doctors timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval.
+Added: 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.
+Added: Recipients may also receive prioritized review of their submission and potential Medicare reimbursement through the Medicare Coverage of Innovative Technology payment pathway.
+Added: 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.
+Added: Designation for any expedited review procedure does not ensure that we will ultimately obtain regulatory clearance or approval for such product.
FDA Enforcement
4 unchanged sentences
● 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 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;
−Removed: ● corrections and removal reporting regulations, which require that manufacture’s 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;
+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
+Added: 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: ● 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;
● post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
10 unchanged sentences
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: 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: 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.
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.
14 unchanged sentences
We cannot predict the ultimate timing or form of any such guidance or regulation or their potential impact.
−Removed: If adopted, such a regulatory approach by the FDA may lead to an increased regulatory burden, including additional costs and delays in introducing new tests.
+Added: If adopted, such a regulatory
+Added: approach by the FDA may lead to an increased regulatory burden, including additional costs and delays in introducing new tests.
While the ultimate impact of the FDA’s approach is unknown, it may be extensive and may result in significant change.
13 unchanged sentences
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, which must be fully implemented by May 2022, the requirements increase and involve assessment by a notified body.
−Removed: Uman’s Nf-L ELISA assay kit is classified as class B product.
−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.
−Removed: clinical evidence and post-market activities).
+Added: Under the new IVD Regulation, the requirements increase and involve assessment by a notified body for class B, C and D products.
+Added: Uman’s Nf-L ELISA assay kit is classified as class B product and must fully implement the new IVD Regulation by May 2027.
+Added: 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).
The work to meet the new technical requirements is on-going.
1 unchanged sentence
When completed, the available technical documentation will be assessed by an external consultant.
−Removed: When all requirements are met, a notified body will be contracted and the certification initiated.
+Added: When all requirements are met, a notified body will be contacted, and the certification initiated.
Other Governmental Regulation
+Added: Data Privacy and Security Laws and Regulations
+Added: 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: 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.
+Added: 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.
+Added: federal and state, international
+Added: and industry levels.
+Added: 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.
+Added: 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: Rules under HIPAA and HITECH include specific security standards and breach notification requirements.
+Added: 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: Generally Quanterix is not a Covered Entity, however, we may operate as a Business Associate to Covered Entities under certain circumstances.
+Added: In addition to the regulation of personal health information, a number of states have also adopted laws and regulations that may affect our privacy and data security practices for other kinds of personally identifiable information, such as state laws that govern the use, disclosure and protection of sensitive personal information, such as social security numbers, or that are designed to protect credit card account data.
+Added: State consumer protection laws may also establish privacy and security standards for use and management of personally identifiable information, including information related to consumers and care providers.
+Added: Outside the U.S., we are impacted by the privacy and data security requirements at the international, national and regional level, and on an industry specific basis.
+Added: Legal requirements in foreign countries relating to the collection, storage, handling and transfer of personal data and potentially intellectual property continue to evolve with increasingly strict enforcement regimes.
+Added: More privacy and security laws and regulations are being adopted, and more are being enforced, with potential for significant financial penalties.
+Added: In the E.U., stringent data protection and privacy rules which substantially impact the use of patient data across the healthcare industry became effective in May 2018.
+Added: General Data Protection Regulation (GDPR) applies uniformly across the E.U.
+Added: and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.
+Added: The GDPR also requires companies processing personal data of individuals residing in the E.U.
+Added: to comply with E.U.
+Added: privacy and data protection rules.
+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 cost expenditures or changes in products or business that increase competition or reduce revenue.
+Added: Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities.
+Added: Environmental Health and Safety Laws
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.
8 unchanged sentences
As of December 31, 2021, we had 460 full-time employees, of which 135 work in sales, sales support, field service, and marketing, 125 work in engineering and research and development, 125 work in manufacturing and operations and 75 work in general and administration.
−Removed: Of our 314 full-time employees, 273 were located in the United States and 41 were located in ten foreign countries.
+Added: Of our 460 full-time employees, 407 were located in the United States and 53 were located in twelve foreign countries.
None of our employees are represented by a labor union or subject to a collective bargaining agreement.
−Removed: Historically, we have experienced a turnover rate that is lower than the industry average and attribute that to our unique culture that stresses the impact our work has on the eradication of human diseases including Alzheimer’s, cancer and COVID.
+Added: 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.
We invest in creating a diverse, inclusive and safe work environment where our employees can deliver their workplace best every day.
+Added: 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.
2 unchanged sentences
In support of our inclusive culture, we sponsor an internal Diversity, Equity and Inclusion Committee comprised of employees and executives, provide respectful workplace training to strengthen employee understanding and consciously strive to recruit a diverse talent pool across all levels of the organization.
−Removed: As of December 31, 2020, approximately 45% of our employees were women and approximately 30%
−Removed: were non-white.
+Added: As of December 31, 2021, approximately 42% of our employees were women and approximately 30% were non-white.
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:
6 unchanged sentences
We expect all of our employees and contractors to observe the highest levels of business ethics, integrity, mutual respect, tolerance and inclusivity.
−Removed: Our employee handbook and Corporate Code of Conduct and Ethics set forth policies reflecting these values and also provides direction for registering complaints in the event of any violation of our policies.
+Added: Our employee handbook and Corporate Code of Conduct and Ethics set forth policies reflecting these values and also provide direction for registering complaints in the event of any violation of our policies.
An “open door” policy is maintained at all levels of the organization and any form of retaliation against an employee is strictly prohibited.
16 unchanged sentences
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.