−Removed: We are a premier life science technology company that is designing, developing, and manufacturing advanced sequencing solutions that enable scientists and clinical researchers to improve their understanding of the genome and ultimately, resolve genetically complex problems.
−Removed: Our products and technology under development stem from two highly differentiated core technologies focused on accuracy, quality, and completeness, which include our HiFi long-read sequencing technology and our Sequencing by Binding (SBB ® ) short-read sequencing technology.
+Added: We are a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions that enable scientists and clinical researchers to improve their understanding of the genome and ultimately, resolve genetically complex problems.
+Added: Our products and technology under development stem from two highly differentiated core technologies focused on accuracy, quality, and completeness, which include our HiFi long-read sequencing technology and our Sequencing by Binding (SBB TM ) short-read sequencing technology.
Our products address solutions across a broad set of applications including human genetics, plant and animal sciences, infectious disease and microbiology, oncology, and other emerging applications.
−Removed: Long-read sequencing was recognized by the journal Nature Methods as its “method of the year” for 2022 for its contributions to biological understanding and future potential.
−Removed: Our focus is on creating some of the world`s most advanced sequencing systems to provide our customers the most complete and accurate view of genomes, transcriptomes, and epigenomes.
+Added: Lo ng-read sequencing was recognized by the journal Nature Methods as its “method of the year” for 2022 for its contributions to biological understanding and future potential.
+Added: Long-read sequencing has been applied to produce telomere-to-telomere genomes of humans, pangenome references, and has been recognized for its ability to provide more complete views of human variation .
+Added: Our focus is on creating some of the world's most advanced sequencing systems to provide our customers with the most complete and accurate view of genomes, transcriptomes, and epigenomes.
Our customers include academic and governmental research institutions, commercial testing and service laboratories, genome centers, public health labs, hospitals and clinical research institutes, contract research organizations (CROs), pharmaceutical companies, and agricultural companies.
Recent Developments
−Removed: In 2023, we commercially released two new sequencing platforms, Revio TM and Onso TM .
−Removed: Revio is a new long-read sequencing system designed to enable the use of HiFi sequencing for large studies in human genetics, cancer research, and agricultural genomics.
−Removed: Commercial shipments for Revio commenced in the first quarter of 2023, and 173 systems have since been shipped to more than twenty countries as of December 31, 2023.
−Removed: We released SMRT Link 13.0 software on the Revio system which includes the adaptive loading feature for consistent run performance, run preview for improved lab efficiency, and expanded application support with functionality to sequence shorter and longer fragments of DNA.
−Removed: Onso, a short-read DNA sequencing system, is designed to deliver industry-leading sensitivity and specificity for novel insights in oncology, disease research, and other applications.
−Removed: We commenced customer shipments of Onso in the third quarter of 2023.
−Removed: In August 2023, we acquired Apton Biosystems to accelerate the development of a high-throughput platform based on the SBB chemistry utilized by Onso.
−Removed: Through acquiring Apton, we obtained expertise in state-of-the-art optics and image processing and a novel clustering method and chemistry designed to enable the sequencing of billions of clusters of DNA on one flow cell.
−Removed: We also develop products used to prepare molecules for sequencing on our platforms.
−Removed: In the fourth quarter of 2023, we commenced commercial shipments for a new Kinnex TM line of products used to concatenate small molecules into larger fragments to optimize the output on HiFi sequencing systems like Revio.
−Removed: The Kinnex products are designed for various applications in RNA and amplicon sequencing.
−Removed: As of December 31, 2023, we received orders from over 70 customers.
+Added: In 2024, we launched Vega TM , a revolutionary new benchtop sequencer designed to make accurate long-read sequencing accessible to more laboratories than ever before.
+Added: Vega delivers up to 60 gigabases of long reads per run and is designed to provide accurate HiFi reads and high-quality genomic, transcriptomic, and epigenetic data for individual labs.
+Added: Additionally, in the fourth quarter of 2024, we launched SPRQ chemistry for the Revio system.
+Added: The SPRQ chemistry will increase the efficiency of loading on Revio SMRT ® Cells, reducing DNA input requirements to just 500 ng, a 75% reduction.
+Added: These lower input requirements will allow HiFi sequencing to support new sample types, like saliva and tumors.
+Added: The chemistry is also expected to improve sequencing performance, providing an approximately 33% increase in sequencing yield per SMRT Cell.
+Added: Collectively, these enhancements are designed to enable each Revio instrument to sequence up to 2,500 human whole genomes per year at a cost of just under $500 per human genome.
+Added: In the first quarter of 2024, we commenced commercial shipments for the PureTarget repeat expansion panel, a new solution designed to comprehensively analyze 20 genes associated with serious neurological disorders, including challenging-to-sequence genes with tandem repeat expansions.
+Added: We also released the Nanobind PanDNA kit as a single kit that supports extraction of high quality DNA from many sample types, and the HiFi prep kit as a scalable and automation-friendly library prep for genomic samples.
Our Mission and Impact
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We believe that unleashing the full potential of genomics will require a level of accuracy and completeness inaccessible to legacy technologies.
−Removed: Accuracy and completeness are central to our product development strategy;
+Added: Accuracy and completeness are central to our product
+Added: Fiscal 2024 Form 10-K
+Added: development strategy;
thus, we have created some of the most innovative and high-quality genomics solutions on the market.
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• identify and characterize pathogens to inform regional, national, and global public health agencies for preparation and response to rapidly evolving microorganisms;
+Added: Fiscal 2024 Form 10-K
• characterize complex microbial communities to understand their role in human, animal, and environmental health.
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In Plant and Animal Sciences, academic, government and corporate researchers are using our technology to explore and catalog the genetic and biological diversity of organisms for the breeding, propagation, and production of crops and livestock while conserving the planet’s natural resources.
−Removed: PacBio HiFi sequencing enables researchers to build high quality de novo reference genomes and transcriptomes to study variations across species enabling improvements to global conservation initiatives and support the breeding and production of resilient and higher yielding crops to meet the world's growing population and demand.
+Added: Our HiFi sequencing enables researchers to build high quality de novo reference genomes and transcriptomes to study variations across species enabling improvements to global conservation initiatives and support the breeding and production of resilient and higher yielding crops to meet the world's growing population and demand.
Our Technology, Products, and Solutions
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Our HiFi long-read sequencing protocol was built upon our SMRT sequencing systems, including consumables and software, and offers customized end-to-end workflows for different sequencing applications.
−Removed: Highly accurate, long sequence reads simplify and accelerate data analysis algorithms, reducing the need for error correction steps and/or assembly aspects, depending on the application.
+Added: Highly accurate, long sequence reads simplify and accelerate data analysis algorithms, reducing the need for error correction and/or assembly, depending on the application.
Customers use our HiFi long-read sequencing platforms in a wide range of sequencing applications, including whole genome sequencing and de novo genome assembly, long-range phasing, targeted sequencing, full-length RNA and single-cell sequencing, characterization of metagenomic communities and other mixed DNA samples, viral genome sequencing, and others.
−Removed: Our technology is also capable of detecting epigenetic markers simultaneously by analyzing the kinetics of DNA polymerization that is affected, and thereby detectable, by epigenetic markers such as 5-methylcytosine or N 6 -methyladenine.
+Added: Our technology is also capable of detecting epigenetic markers
+Added: Fiscal 2024 Form 10-K
+Added: simultaneously by analyzing the kinetics of DNA polymerization that is affected, and thereby detectable, by epigenetic markers such as 5-methylcytosine or N 6 -methyladenine.
SMRT Technology
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SMRT Sequencing is based on following the activity of DNA polymerase on individual DNA molecules in real time that occurs on our SMRT Cells that are monitored and analyzed within our HiFi long-read sequencing systems:
−Removed: the Revio system, Sequel II system, Sequel IIe system, and Sequel system.
+Added: the Revio system, Vega system, Sequel ® system, Sequel II system, and Sequel IIe system.
Carried out on SMRTbell ® templates, which attach hairpin adapters to the ends of double-stranded DNA molecules to be sequenced, SMRT sequencing allows for the successive sequencing of both the forward and reverse strands of the individual DNA molecule occurring multiple times, thereby allowing for the same base of the same molecule to be sequenced more than once in a sequencing run.
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HiFi reads typically are 15-20 kilobases in size, depending on the input fragments, providing sufficient read length with our accuracy to support a multitude of applications across human health, plant and animal, and microbiology, according to research we performed in collaboration with other researchers, subsequently published in Scientific Data in 2020.
+Added: According to an article published by Genome Research in 2024, users are able to increase rare disease solve rates using HiFi over short read sequencing.
+Added: HiFi was also cited as having the ability to resolve complex rearrangements in rare disease cases, subsequently published in an article on Nature.com in 2024.
The ability to generate single-DNA molecule sequence reads that are both long and highly accurate allows researchers to obtain more contiguous, complete, and accurate genomic data, thereby allowing for greater insights into the complexity of biological systems.
HiFi Long-Read Sequencing Instruments:
−Removed: Revio system + Sequel systems
−Removed: Our Revio, Sequel, Sequel II, and Sequel IIe instruments conduct, monitor, and analyze single-molecule biochemical reactions in real time.
+Added: Revio system, Vega system, and Sequel systems
+Added: Our Revio, Vega, Sequel, Sequel II, and Sequel IIe instruments conduct, monitor, and analyze single-molecule biochemical reactions in real time.
The instruments use extremely sensitive imaging systems to collect the light pulses emitted by fluorescent reagents allowing the observation of biological processes.
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Our core sequencing kits contain reagents required for on-instrument, real-time sequencing, including phospholinked nucleotides.
−Removed: We have developed and offered a new line of Kinnex kits with companion SMRT Link software to enable high-throughput, scalable, cost-effective RNA applications including bulk RNA, single-cell RNA, and 16S rRNA sequencing.
−Removed: The Kinnex kits are built upon the Multiplexed Array Sequencing (MAS-Seq) method for concatenating smaller amplicons into larger fragments to sequence on PacBio's long read sequencers, increasing the molecular yield by up to 16-fold.
+Added: Fiscal 2024 Form 10-K
+Added: We have developed and are offering a new line of Kinnex TM kits with companion SMRT Link software to enable high-throughput, scalable, cost-effective RNA applications including bulk RNA, single-cell RNA, and 16S rRNA sequencing.
+Added: The Kinnex kits are built upon the Multiplexed Array Sequencing (MAS-Seq) method for concatenating smaller amplicons into larger fragments to sequence on PacBio's long read sequencers, significantly increasing the molecular yield.
Throughput increase in these key RNA applications where the dynamic range of different RNA isoforms (bulk and single-cell) or microbial species (16S) can vary by orders of magnitude, enables characterization of these complex RNA samples while drastically reducing sequencing need.
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Finally, our clustering and sequencing kits contain all reagents required for generating sequence ready clusters on flow cell and performing SBB sequencing reactions on instrument, respectively.
+Added: Fiscal 2024 Form 10-K
Our Strategy for Growth
−Removed: To enable the promise of genomics, our strategy includes the following key elements:
−Removed: • Increase technology adoption by increasing market share via new customer acquisition, continue Sequel II conversions to Revio, and scale Onso production;
−Removed: • Leverage innovation to complete development of new sequencing platforms and launch on-market system improvements;
−Removed: • Build upon clinical momentum by expanding HiFi usage in large-scale programs and translational research projects;
−Removed: • Drive towards positive cash flow through gross margin expansion, disciplined operating expense management, and a focus on working capital.
+Added: Our main objectives are to grow revenue and expand gross margins through the following four activities:
+Added: • Enabling the full-scale release of the Vega benchtop platform to broaden our market reach.
+Added: We believe this platform broadens the long-read market opportunity.
+Added: • Accelerating samples onto the Revio platform via SPRQ chemistry and application kits.
+Added: The SPRQ chemistry enables the sub-$500 HiFi genome, improves methylation detection capabilities, and achieves a 75% reduction in DNA input requirements for human whole genome sequencing.
+Added: These features can drive more samples onto HiFi sequencing than ever before.
+Added: • Investing in future product launches to diversify our offerings.
+Added: We continue to develop sequencing systems designed to increase throughput and lower the cost to sequence a genome, which we believe will allow us to address an even larger part of the market.
+Added: Additionally, we continue to develop kitted-solutions, like our Kinnex Full-length RNA kits and PureTarget, and enhance our on-market sequencers with products like SPRQ chemistry to drive more sequencing volume.
+Added: • Progressing our clinical strategy to improve outcomes and create durability.
+Added: In 2024 Revio was increasingly being used in laboratory-developed test (“LDT”) and clinical research settings to consolidate multiple tests and address complex genetic challenges.
Marketing, Sales, Service, and Support
−Removed: We market our products through a global sales force and through distribution partners in Asia and Australia, certain parts of Europe, the Middle East and Africa, and Latin America.
+Added: We market our products through a global sales force and through distribution partners in Australia, certain parts of Asia, Europe, the Middle East, Africa, Central America and South America.
We plan to continue to invest in growing our marketing, sales, service, and support resources as we drive continued adoption of products, launch new products, and expand our customer base.
−Removed: Our business is subject to seasonal trends.
−Removed: See the Risk Factors section, specifically the risk factor titled Our operating results fluctuate from quarter to quarter and year over year, which makes our future results difficult to predict and could negatively impact the market price of our common stock , for additional information.
Our customers include academic and governmental research institutions, commercial testing and service laboratories, genome centers, public health labs, hospitals and clinical research institutes, contract research organizations ("CROs"), pharmaceutical companies, and agricultural companies.
−Removed: In general, our customers will isolate, prepare, and analyze genetic samples using PacBio sequencing systems in their own laboratories, or they will send their genetic samples to third-party service providers who in turn will sequence the samples with PacBio systems and provide the sequence data back to the customer for further analysis.
+Added: In general, our customers will isolate, prepare, and analyze genetic samples using PacBio systems in their own laboratories, or they will send their genetic samples to third-party service providers who in turn will sequence the samples with PacBio systems and provide the sequence data back to the customer for further analysis.
For example, customers in academic research institutions may have bacteria, animal, or human DNA samples isolated from various sources while agricultural biology companies may have DNA samples isolated from different strains of rice, corn, or other crops.
−Removed: For the year ended December 31, 2023, no single customer accounted for 10% or more of our total revenue.
−Removed: For the years ended December 31, 2022, and 2021, one customer accounted for approximately 12% and 13% of our total revenue, respectively.
+Added: We receive a significant portion of our revenue from a limited number of customers, many of whom make large purchases on a purchase-order basis.
+Added: For the years ended December 31, 2024, and 2023, no customer accounted for 10% or more of our total revenue.
+Added: For the year ended December 31, 2022, one customer exceeded 10% of our total revenue.
We believe that the majority of our current customers are early adopters of sequencing technology.
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We define backlog as purchase orders or signed contracts from our customers, which we believe are firm and for which we have not yet recognized revenue.
−Removed: We expect to convert the majority of this backlog to revenue during 2024;
+Added: We expect to convert the majority of this
+Added: Fiscal 2024 Form 10-K
+Added: backlog to revenue during 2025;
however, our ability to do so is subject to customers who may seek to cancel or delay their orders even if we are prepared to fulfill them.
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Our key manufacturing and service facility in Menlo Park, California has received ISO 13485 and ISO 9001 certifications for the design, development, manufacture, distribution, installation, and servicing of its nucleic acid sequencing platforms.
−Removed: We utilize subcontract manufacturers for components of the manufacturing process.
−Removed: We purchase both custom and off-the-shelf components from a large number of suppliers and subject them to significant quality specifications.
+Added: We utilize domestic and international subcontract manufacturers for components of the manufacturing process.
+Added: We purchase both custom and off-the-shelf components from a large number of suppliers worldwide and subject them to significant quality specifications.
We periodically conduct quality audits of most of our critical suppliers and have established a supplier qualification program.
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We are currently developing higher throughput platforms that utilize our HiFi long-read sequencing and SBB short-read sequencing technologies.
−Removed: We also are developing a benchtop HiFi platform intended to improve accessibility for smaller laboratories, and we continue to extend our on-market platforms, Revio and Onso.
In addition to platform development, we also innovate across end-to-end workflows to improve usability, as well as develop new applications for the advancement of human health.
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Developing and maintaining a strong intellectual property portfolio is an important element of our business.
−Removed: We have sought, and will continue to seek, patent protection for our SMRT and SBB technology, for improvements to our SMRT kit and SBB technology, as well as for any of our other technologies where we believe such protection will be advantageous.
+Added: We have sought, and will continue to seek, patent protection for our SMRT kit and SBB technology, for improvements to our SMRT kit and SBB technology, as well as for any of our other technologies where we believe such protection will be advantageous.
Our current patent portfolio, including patents exclusively licensed to us, is directed to various technologies, including SMRT nucleic acid sequencing and other methods for analyzing biological samples, zero-mode waveguide ("ZMW") arrays, surface treatments, phospholinked nucleotides and other reagents for use in nucleic acid sequencing, optical short-read nucleic acid sequencing, nucleic acid preparation, and purification components and systems, processes for identifying nucleotides within nucleic acid sequences, and processes for analysis and comparison of nucleic acid sequence data.
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(“Bionano”), Ultima Genomics, Inc.
−Removed: (“Ultima”) and Singular Genomics Systems, Inc.
−Removed: (“Singular”).
+Added: (“Ultima”), Singular Genomics Systems, Inc.
+Added: (“Singular”) and 10x Genomics, Inc.
These companies may have different levels of financial, technical, manufacturing, administrative, and support resources available to them.
−Removed: We expect the competition to intensify within the overall nucleic acid sequencing market as there are also several companies developing new sequencing technologies, products and/or services.
+Added: We expect continued intense competition within the overall nucleic
+Added: Fiscal 2024 Form 10-K
+Added: acid sequencing market as there are several companies developing new sequencing technologies, products and/or services.
Increased competition may result in pricing pressures, which could harm our sales, profitability, or share of supply.
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Medical devices to be commercially distributed in the United States must receive from the FDA either clearance of a pre-market notification, known as 510(k), or pre-market approval pursuant to the FDC Act prior to marketing, unless subject to an exemption.
−Removed: We intend to label and sell our products for research use only (“RUO”) and expect to sell them to research customers in various settings, including academic institutions, life sciences and research laboratories that conduct research, and biopharmaceutical and biotechnology companies for non-diagnostic and non-clinical purposes.
+Added: We currently label and sell our products for research use only (“RUO”) and primarily sell them to research customers in various settings, including academic institutions, life sciences and research laboratories that conduct research, and biopharmaceutical and biotechnology companies for non-diagnostic and non-clinical purposes.
Our current RUO products are not intended or promoted for use in clinical practice in the diagnosis of disease or other conditions, and they are labeled for research use only, not for use in diagnostic procedures.
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If we wish to label and expand product lines to address the diagnosis of disease, regulation by governmental authorities in the United States and other countries will become an increasingly significant factor in development, testing, production, and marketing.
−Removed: In the future, products that we may develop in the molecular
−Removed: diagnostic markets, depending on their intended use, may be regulated as medical devices or in vitro diagnostic products (“IVDs”) by the FDA and comparable agencies in other countries.
+Added: In the future, products that we may develop in the molecular diagnostic markets, depending on their intended use, may be regulated as medical devices or in vitro diagnostic products (“IVDs”) by the FDA and comparable agencies in other countries.
In the U.S., if we market our products for use in performing clinical diagnostics, such products would be subject to regulation by the FDA under pre-market and post-market control as medical devices, unless an exemption applies, and we would be required to obtain either prior 510(k) clearance or prior pre-market approval from the FDA before commercializing the product.
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Changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time during the development or marketing of our products.
−Removed: In November 2013, the FDA issued a final guidance on products labeled for research use only, which, among other things, reaffirmed that a company may not make any clinical or diagnostic claims about an RUO product, stating that merely including a labeling statement that the product is for research purposes only will not necessarily render the device exempt from the FDA’s clearance, approval, or other regulatory requirements if the totality of circumstances surrounding the distribution of the product indicates that the manufacturer knows its product is being used by customers for diagnostic uses or the manufacturer intends such a use.
−Removed: These circumstances may include, among other things, written or verbal marketing claims regarding a product’s performance in clinical diagnostic applications and a manufacturer’s provision of technical support for such activities.
+Added: In 2013, the FDA issued a final guidance on products labeled for research use only, which, among other things, reaffirmed that a company may not make any clinical or diagnostic claims about an RUO product, stating that merely including a labeling statement that the product is for research purposes only will not necessarily render the device exempt from the FDA’s clearance, approval, or other regulatory requirements if the totality of circumstances surrounding the distribution of the product indicates that the manufacturer knows its product is being used by customers for diagnostic uses or the manufacturer intends such a use.
+Added: These circumstances
+Added: Fiscal 2024 Form 10-K
+Added: may include, among other things, written or verbal marketing claims regarding a product’s performance in clinical diagnostic applications and a manufacturer’s provision of technical support for such activities.
If FDA were to determine, based on the totality of circumstances, that our products labeled and marketed for RUO are intended for diagnostic purposes, they would be considered medical devices that will require clearance or approval prior to commercialization.
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Obtaining the requisite regulatory approvals, including the FDA quality system inspections that are required for PMA approval, can be expensive and may involve considerable delay.
−Removed: The regulatory approval process for such products may be significantly delayed, may be significantly more expensive than anticipated,
−Removed: and may conclude without such products being approved by the FDA.
+Added: The regulatory approval process for such products may be significantly delayed, may be significantly more expensive than anticipated, and may conclude without such products being approved by the FDA.
Without timely regulatory approval, we will not be able to launch or successfully commercialize such diagnostic products.
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If the FDA or other regulatory authorities assert that any of our RUO products are subject to regulatory clearance or approval, our business, financial condition, or results of operations could be adversely affected.
−Removed: For example, in some cases, our customers, including laboratories that offer services as part of our certified service provider program, may use our RUO products in their own laboratory-developed tests (“LDTs”) or in other FDA-regulated products for clinical diagnostic use.
+Added: For example, in some cases, our customers, including laboratories that offer services as part of our certified service provider program, may use our RUO products in their own LDTs or in other FDA-regulated products for clinical diagnostic use.
The FDA has historically exercised enforcement discretion in not enforcing the medical device regulations against LDTs and LDT manufacturers.
−Removed: However, on October 3, 2014, the FDA issued two draft guidance documents that set forth the FDA’s proposed risk-based framework for regulating LDTs, which are designed, manufactured, and used within a single laboratory.
−Removed: In January 2017, the FDA announced that it would not issue final guidance on the oversight of LDTs and LDT manufacturers but would seek further public discussion on an appropriate oversight approach and give Congress an opportunity to develop a legislative solution.
The FDA has issued warning letters to genomics labs for illegally marketing genetic tests that claim to predict patients’ responses to specific medications, noting that the FDA has not created a legal “carve-out” for LDTs and retains discretion to take action when appropriate, such as when certain genomic tests raise significant public health concerns.
−Removed: As laboratories and manufacturers develop more complex genetic tests and diagnostic software, the FDA may increase its regulation of LDTs.
+Added: As laboratories and manufacturers
+Added: Fiscal 2024 Form 10-K
+Added: develop more complex genetic tests and diagnostic software, the FDA may increase its regulation of LDTs.
Legislative and administrative proposals to amend the FDA's oversight of LDTs have been introduced in recent years, including the Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act”).
−Removed: In September 2022, Congress passed the FDA user fee reauthorization legislation without substantive FDA policy riders, including the VALID Act, but Congress may revisit the policy riders and enact other FDA programmatic reforms in the future.
−Removed: In October 2023, through rulemaking, the FDA proposed to amend the definition of “in vitro diagnostic products” in FDA regulations to include laboratories that manufacture such products and to phase out the FDA’s general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would be regulated similarly to IVDs.
−Removed: It is unclear when the FDA will finalize and begin enforcing such rule.
−Removed: Any future legislative or administrative rule making or oversight of LDTs and LDT manufacturers, if and when finalized, may impact the sales of our products and how customers use our products, and may require us to change our business model in order to maintain compliance with these laws.
−Removed: We would become subject to additional FDA requirements if our products are determined to be medical devices or if we elect to seek 510(k) clearance or pre-market approval.
+Added: In September 2022, Congress passed the FDA user fee reauthorization legislation without substantive FDA policy riders, including the VALID Act.
+Added: In May 2024, the FDA issued a final rule that phases out its enforcement discretion for most LDTs and amends the FDA’s regulations to make explicit that in vitro diagnostics are medical devices under the FDCA, including when the manufacturer of the diagnostic product is a laboratory.
+Added: This final rule is being challenged in federal courts.
+Added: Further, in June 2024, the U.S.
+Added: Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous.
+Added: This landmark Supreme Court decision may invite various stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, including this LDT final rule.
+Added: The new Trump administration, including changes in the leadership at the FDA, may issue new policies and regulations that can impact the compliance status of our products or that of our customers.
If our products become subject to FDA regulation as medical devices, we would need to invest significant time and resources to ensure ongoing compliance with FDA quality system regulations and other post-market regulatory requirements.
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In the future, to the extent we develop any clinical diagnostic assays, we may pursue payment for such products through a diverse and broad range of channels and seek coverage and reimbursement by government health insurance programs and commercial third-party payors for such products.
−Removed: In the United States, there is no
−Removed: uniform coverage for clinical laboratory tests.
+Added: In the United States, there is no uniform coverage for clinical laboratory tests.
The extent of coverage and rate of payment for covered services or items vary from payor to payor.
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Foreign Corrupt Practices Act, the U.K.
−Removed: Bribery Act, and other local laws prohibiting corrupt payments to governmental officials, anti-competition regulations and sanctions imposed by the U.S.
+Added: Bribery Act, and other local laws prohibiting corrupt payments to governmental
+Added: Fiscal 2024 Form 10-K
+Added: officials, anti-competition regulations and sanctions imposed by the U.S.
Office of Foreign Assets Control, and other similar laws and regulations.
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As of December 31, 2024, we had 575 full-time employees.
−Removed: Of these employees, 317 were in research and development, 91 were in operations, 45 were in service, 226 were in marketing, sales, and customer support, and 117 were in general and administration.
+Added: Of these employees, 207 were in research and development, 67 were in operations, 39 were in service, 187 were in marketing and sales, and 75 were in general and administration.
With the exception of our field-based sales, marketing, and service teams, the majority of our employees are in California.
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These programs are highlighted and updated regularly on our internal benefits platform.
+Added: Fiscal 2024 Form 10-K
Diversity, Equity, and Inclusion
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Training and Development
−Removed: We believe in encouraging employees to becoming lifelong learners by providing ongoing learning and leadership training opportunities.
+Added: We believe in encouraging employees to become lifelong learners by providing ongoing learning and leadership training opportunities.
We provide a scaled learning platform of on-demand and virtual classroom learning focused on personal and professional development.
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The information posted on, or that can be accessed through, our website is not incorporated by reference into this Annual Report on Form 10-K, and the inclusion of our website address is an inactive textual reference only.
−Removed: Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge through the “Investor Relations” section of our website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
+Added: Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act are available free of charge through the “Investor Relations” section of our website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
The SEC also maintains a website that contains our SEC filings.
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The contents of our website and our X account are not incorporated by reference into this Annual Report on Form 10-K or in any other report or document we file with the SEC, and any references to our website or X account are intended to be inactive textual references only.
+Added: Fiscal 2024 Form 10-K
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.