Our mission is to accelerate the mastery of biology to advance human health.
−Removed: We are a life science technology company building products to interrogate, understand and master biology.
−Removed: Our integrated solutions include instruments, consumables and software for analyzing biological systems at a resolution and scale that matches the complexity of biology.
+Added: We are a life science technology company focused on building innovative products to interrogate, understand and master biology.
+Added: Our integrated platform solutions include instruments, consumables and software for analyzing biological systems at a resolution and scale that matches the complexity of biology.
We have built deep expertise across diverse disciplines including chemistry, biology, hardware and software.
Innovations in all of these areas have enabled our rapidly expanding suite of products, which allow our customers to interrogate biological systems at previously inaccessible resolution and scale.
−Removed: Our products have enabled researchers to make fundamental discoveries across multiple areas of biology, including oncology, immunology and neuroscience, and have helped empower the single cell revolution hailed by Science magazine as the 2018 “Breakthrough of the Year.” Our products have won many awards, including among others the technological advancements in single cell multimodal omics hailed by Nature Methods journal as the 2019 “Method of the Year” and the technological advancements in spatially resolved transcriptomics hailed by Nature Methods journal as the 2020 “Method of the Year.” Between 2015 and 2021, a total of seven 10x products have been recognized by The Scientist magazine on their annual Top 10 Innovations list, an annual list of newly released products that have the potential to generate the biggest impact on scientific research.
+Added: Our products have enabled researchers to make fundamental discoveries across multiple areas of biology, including oncology, immunology and neuroscience, and have helped empower the single cell revolution hailed by Science magazine as the 2018 “Breakthrough of the Year.” Our products have won many awards, including among others the technological advancements in single cell multimodal omics hailed by Nature Methods journal as the 2019 “Method of the Year” and the technological advancements in spatially resolved transcriptomics hailed by Nature Methods journal as the 2020 “Method of the Year.” Through our compatible partner program, our partnership with two long read sequencing companies launched products and protocols providing the ability to obtain full-length isoforms at single cell resolution.
+Added: This groundbreaking capability was highlighted as part of the Nature Methods 2022 “Method of the Year” Long-read sequencing.
+Added: Since 2015, a total of seven 10x products have been recognized by The Scientist magazine on their annual Top 10 Innovations list, an annual list of newly released products that have the potential to generate the biggest impact on scientific research.
Since launching our first product in mid-2015 through December 31, 2022, cumulatively we have sold 4,630 instruments to researchers around the world, including all of the top 100 global research institutions as ranked by Nature in 2021 based on publications and all of the top 20 global biopharmaceutical companies by 2021 research and development spend.
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The human body consists of over 40 trillion cells, each with a genome of 3 billion DNA base pairs and a unique epigenetic program regulating the transcription of tens of thousands of different RNAs, which are then translated into tens of thousands of different proteins.
−Removed: Progress in the life sciences will require the ability to measure biological systems in a much more comprehensive fashion and to experiment on biological systems at fundamental resolutions and massive scales, which are inaccessible with existing technologies.
+Added: Progress in the life sciences will require the ability to measure biological systems in a much more comprehensive fashion and to experiment on biological systems at fundamental resolution and on massive scale, which are inaccessible with previously existing technologies.
We believe that our technologies overcome these limitations, unlocking fundamental biological insights essential for advancing human health.
−Removed: Resolution and scale are the imperatives underlying our technologies and products.
−Removed: Our Chromium, Visium and forthcoming Xenium product lines provide this resolution and scale along distinct but complementary dimensions of biology.
−Removed: Our Chromium products enable high throughput analysis of individual biological components, such as up to millions of single cells.
−Removed: They use our precisely engineered reagent delivery system to divide a sample into individual components in up to a million or more partitions, enabling large numbers of parallel micro-reactions.
−Removed: In this manner, a large population of cells can be segregated into partitions and analyzed on a cell by cell basis.
−Removed: Our Visium products enable analysis of biological molecules within their spatial context, providing the locations of analytes that give insight into higher order biological structure and function.
−Removed: Our Visium platform uses high density DNA arrays with DNA sequences that encode the physical locations of biological analytes within a sample, such as a tissue section.
−Removed: Our products utilize our sensitive and robust molecular assays to convert biological analytes into detectable signals, enabling researchers to obtain vast amounts of information about diverse biological analytes together with their single cell and spatial context.
−Removed: Our forthcoming Xenium platform for in situ analysis is being designed to give scientists the ability to not only locate and type cells in their tissue context, but also to address a variety of specific questions based on previous knowledge of their sample often discovered using our Chromium and Visium platforms.
−Removed: Finally, we provide highly sophisticated and scalable software for analyzing the raw data researchers generate and presenting it in a form that is readily understood by biologists.
−Removed: Our product portfolio consists of multiple integrated solutions that include instruments, consumables and software.
−Removed: These solutions guide customers through the workflow from sample preparation to sequencing on third-party sequencers that are commonly available in research settings to subsequent analysis and visualization.
−Removed: Each of our solutions is designed to interrogate a major class of biological information that is impactful to researchers:
−Removed: • Our single cell solutions, all of which run on our Chromium instruments, include:
−Removed: ◦ Low, Standard and High Throughput Single Cell Gene Expression Kits for measuring gene activity on a cell-by-cell basis from entry level to massively large-scale experiments;
−Removed: ◦ Standard and High Throughput Single Cell Immune Profiling Kits for measuring the activity of immune cells and their targets;
−Removed: ◦ Single Cell ATAC (Assay for Transposase Accessible Chromatin) for measuring epigenetics, including the physical organization of DNA;
−Removed: ◦ Single Cell Multiome ATAC+Gene Expression introduced in 2020 for measuring the genetic activity and epigenetic programming in the same cells across tens of thousands of cells in a single experiment.
−Removed: • Our Visium Spatial Gene Expression solution for measuring spatial gene expression patterns across a single fresh-frozen or formalin-fixed paraffin-embedded (FFPE) tissue sample or gene expression and protein co-detection when combined with Immunofluorescence.
−Removed: Our Feature Barcode technology, which is currently compatible with our Single Cell Gene Expression and Immune Profiling solutions, allows researchers to simultaneously measure multiple analytes, such as protein and RNA, within the same set of cells or tissues.
−Removed: Our Targeted Gene Expression solution, which we introduced in 2020, is currently compatible with our Chromium Single Cell Gene Expression, our Chromium Single Cell Immune Profiling and our Visium Spatial Gene Expression Solutions, allows researchers to target the genes most relevant for their research, validate their hypotheses faster and reduce sequencing costs.
−Removed: Our CellPlex solution, which we introduced in 2021, is currently compatible with our Chromium Single Cell Gene Expression solution and allows researchers to increase sample and cell throughput by enabling multiple samples and higher cell loads to be loaded into each Chromium channel, lowering costs per sample and cost per cell for our customers.
−Removed: Collectively, our solutions enable researchers to interrogate, understand and master biology at the appropriate resolution and scale.
−Removed: We believe our solutions, which enable a comprehensive view of biology, target numerous market opportunities across the more than $60 billion global life sciences research tools market.
+Added: Our product portfolio consists of multiple integrated platforms that include instruments, consumables and software.
+Added: These platforms guide customers through the workflow from sample preparation to analysis and visualization.
+Added: Each of our platforms is designed to interrogate a major class of biological information that is impactful to researchers at high resolution and scale:
+Added: • Our Chromium platform enables high-throughput analysis of individual biological components.
+Added: It is a precisely engineered reagent delivery system that divides a sample into individual components in up to a million or more partitions, enabling large numbers of parallel micro-reactions.
+Added: In this manner, for example, the individual single cells of a large population of cells can be segregated so that each cell resides in its own partition.
+Added: Each partition then behaves as a micro-scale reaction vessel in which its contents are barcoded with a DNA sequence that specifically identifies those contents as being distinct from the contents of other partitions.
+Added: Once biological material in each partition is barcoded, they can then be pooled and sequenced together.
+Added: Finally, the barcode sequences can be used to easily tease apart information originating from different partitions.
+Added: Our approach to partitioning and barcoding gives researchers the ability to measure many discrete biological materials and/or perform many different experiments in parallel, providing tremendous resolution and scale.
+Added: • Our Visium platform empowers researchers to identify where biological components are located and how they are arranged with respect to each other, otherwise referred to as “spatial analysis.” Our Visium platform uses high density DNA arrays which have DNA barcode sequences that encode the physical location of biological analytes within a sample, such as a tissue section, allowing the spatial location of the analytes to be “read out” using sequencing to create a visual map of the analytes across the sample.
+Added: Similar to partitioning, spatial barcoding with large numbers of probes on an array can unlock tremendous insights, providing high resolution genomic information to visualize analytes across biological tissues.
+Added: • Our Xenium platform for in situ analysis is designed to give scientists the ability not only to locate and type cells in their tissue context, but also to address a variety of specific questions based on previous knowledge of their sample often discovered using our Chromium and Visium platforms.
+Added: Xenium In Situ detects and preserves the cellular localization of hundreds of RNA targets directly in a fresh frozen or formalin-fixed paraffin-embedded (FFPE) tissue section without the need for conventional sequencing, providing researchers with a detailed map of gene expression patterns without sacrificing resolution or target number.
+Added: Collectively, our platforms enable researchers to interrogate, understand and master biology at the appropriate resolution and scale.
+Added: A summary of our solutions based on the platforms follows below.
+Added: We believe our platforms, which enable a comprehensive view of biology, target numerous market opportunities across the more than $67 billion global life sciences research tools market.
We view much of this total market opportunity as ultimately accessible to us due to our ability to answer a broad diversity of biological questions.
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This is supplemented with an extensive and highly specialized customer service infrastructure with PhD-level specialists.
−Removed: We currently have customers in more than 45 countries.
−Removed: Our revenue was $490.5 million and $298.8 million for the years ended 2021 and 2020, respectively, representing an annual growth rate of 64%.
+Added: We currently have customers in 50 countries.
+Added: Our revenue was $516.4 million and $490.5 million for the years ended 2022 and 2021, respectively, representing a year-over-year growth rate of 5%.
We generated net losses of $166.0 million and $58.2 million for the years ended 2022 and 2021, respectively.
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Each gene has the ability to create multiple different mRNAs, resulting in the production of over 100,000 different mRNAs from about 30,000 genes.
−Removed: The complete collection of all of the DNA, mRNA and proteins are called the genome, transcriptome or gene expression profile, and the proteome, respectively.
+Added: The complete collection of all of the DNA, mRNA and proteins are called the genome,
+Added: transcriptome or gene expression profile, and the proteome, respectively.
The epigenome includes molecular configurations and chemical DNA modifications that affect how genes are regulated.
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Both of these efforts have provided substantial value and have been foundational in enabling multiple new research and clinical applications.
−Removed: However, much of the initial promise of the Human Genome Project and subsequent GWAS projects remains
+Added: However, much of the initial promise of the Human Genome Project and subsequent GWAS projects remains unfulfilled.
We believe this is ultimately due to the tremendous underlying complexity of biology.
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Our solutions
−Removed: We have built and commercialized multiple product lines that allow researchers to interrogate, understand and master biological systems at a resolution and scale commensurate with the complexity of biology.
+Added: We have built and commercialized multiple platforms that allow researchers to interrogate, understand and master biological systems at a resolution and scale commensurate with the complexity of biology.
We believe that our products overcome the limitations of existing tools.
−Removed: Our vision, discipline and multidisciplinary approach have allowed us to continuously innovate to develop the platforms, molecular assays and software that underlie our solutions.
+Added: Our vision, discipline and multidisciplinary approach have allowed us to continuously innovate to develop the instruments, consumables and software that underlie our solutions.
Our technological imperatives:
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Thus, our products provide the appropriate levels of both resolution and scale in a manner that allows researchers to easily sift through the complexity to access the underlying biology.
−Removed: Our platforms, molecular assays and software
−Removed: Our Chromium platform, Visium platform, forthcoming Xenium platform, molecular assays and software constitute the building blocks of our integrated solutions.
−Removed: These shared building blocks allow us to rapidly build and improve our solutions for studying biology at the appropriate resolution and scale:
−Removed: Our Chromium platform enables high-throughput analysis of individual biological components.
−Removed: It is a precisely engineered reagent delivery system that divides a sample into individual components in up to a million or more partitions, enabling large numbers of parallel micro-reactions.
−Removed: In this manner, for example, the individual single cells of a large population of cells can be segregated so that each cell resides in its own partition.
−Removed: Each partition then behaves as a micro-scale reaction vessel in which its contents are barcoded with a DNA sequence that specifically identifies those contents as being distinct from the contents of other partitions.
−Removed: Once biological material in each partition is barcoded, they can then be pooled and sequenced together.
−Removed: Finally, the barcode sequences can be used to easily tease apart information originating from different partitions.
−Removed: Our paradigm of partitioning and barcoding gives researchers the ability to measure many discrete biological materials and/or perform many different experiments in parallel, providing tremendous resolution and scale.
−Removed: We have leveraged our Chromium platform to create a suite of solutions that measure biological analytes at the resolution of the single cell, the most fundamental organizational unit of biology.
−Removed: We believe that, in this sense, all of biology is single cell biology and that our single cell solutions can enhance and sharpen a wide array of scientific work in genetics, developmental biology, molecular biology and cell biology.
−Removed: Part of our Chromium platform is our Chromium Connect instrument, which we began shipping during the first quarter of 2020.
−Removed: Chromium Connect automates single cell workflows, maximizing lab productivity while reducing user variability to generate consistent, reproducible single cell sequencing results.
−Removed: Our Visium platform empowers researchers to identify where biological components are located and how they are arranged with respect to each other, otherwise referred to as “spatial analysis.” Our Visium platform uses high density DNA arrays which have DNA barcode sequences that encode the physical location of biological analytes within a sample, such as a tissue section.
−Removed: This solution allows the spatial location of the analytes to be “read out” using sequencing to constitute a visual map of the analytes across the sample.
−Removed: Similar to partitioning, spatial barcoding with large numbers of probes on an array can unlock tremendous insights, providing high resolution genomic information to visualize analytes across biological tissues.
−Removed: Our molecular assays are used with our Chromium and Visium platforms to provide sensitive and robust biochemistries that convert minute amounts of biological analytes into detectable signals.
−Removed: We have created a wide variety of proprietary assays compatible with our platforms for measuring the genome, epigenome, transcriptome and proteome.
−Removed: • Our GEM-RT assay is a highly sensitive technique for detecting mRNA molecules that are in low abundance in single cells.
−Removed: Less sensitive methods easily miss low abundance mRNA molecules, resulting in loss of information about the activities of many important genes that are detectable using our assay.
−Removed: • Our ATAC-seq assay can be used to determine whether particular genes are active or dormant on a system-wide basis and is tremendously useful in studying gene regulation.
−Removed: • Our Feature Barcode assay allows simultaneous multi-omic interrogation of different classes of biological analytes in a sample.
−Removed: Feature Barcode is highly versatile and can be customized to analyze many different classes of analytes for a wide variety of applications.
−Removed: • Our Multiome ATAC+Gene Expression assays enables simultaneous multiomic interrogation of transcriptome and epigenome profiles from singe cells for deeper understanding of gene regulation.
−Removed: • Our Visium Spatial Gene Expression assay, launched in 2019, measures the spatial positions of biological analytes within fresh-frozen tissues at high resolution.
−Removed: In 2021, we launched Visium Spatial Gene Expression for FFPE which consists of a new chemistry applied to FFPE tissues with similarly high sensitivity and spatial resolution as Fresh Frozen samples.
−Removed: • Our Targeted Gene Expression assay profiles a specific set of transcripts from 10x libraries, and enables researchers to maximize on-target sequencing reads.
−Removed: The targeting solution, with comprehensive and customizable pre-designed gene panels, is compatible with both our GEM-RT and Visium platforms.
−Removed: Our forthcoming Xenium platform for in situ analysis is being designed to give scientists the ability to not only locate and type cells in their tissue context, but also to address a variety of specific questions based on previous knowledge of their sample often discovered using our Chromium and Visium platforms.
−Removed: Our software is essential to our mission of accelerating the mastery of biology.
−Removed: Since our platforms and molecular assays enable new levels of resolution and scale, they produce entirely new types of data and at much larger scales than previously achievable.
−Removed: To that end, we have developed sophisticated and scalable software that completes our solutions which we provide to researchers generally free of charge.
−Removed: Our analysis software transforms large amounts of raw data into usable results, giving researchers user friendly tools to dynamically explore these results.
−Removed: As larger and larger amounts of biological data are generated with greater ease, we believe that software tools will become increasingly critical for progress in biology.
−Removed: In the first quarter of 2021, we introduced 10x Genomics Cloud Analysis, which makes it even easier for new 10x users to get started and for our advanced users to scale to larger and more complex experiments.
−Removed: With Cloud Analysis, we are taking the technology that has underpinned and driven our own internal product development for years and bringing it to our customers.
−Removed: Optimized for our software products, Cloud Analysis aims to be the easiest-to-use and fastest way to run 10x analysis available.
−Removed: And because we believe analysis is an integral part of our products, we provide ample cloud analysis at no additional cost for every sample our customers run.
−Removed: Since our founding, we have committed to making software engineering and computational biology world-class, core internal competencies.
−Removed: We believe this deep investment distinguishes us from our competition and is worthwhile because it:
−Removed: • Removes barriers to adoption.
−Removed: With our software, our customers can immediately begin making sense of their experimental data.
−Removed: Without it, they would be forced to develop their own software or wait for the community to do so, slowing down adoption of our products by months or even years;
−Removed: • Accelerates pull-through.
−Removed: Easy-to-use, efficient software helps our customers analyze their data and complete their experiments and studies faster, enabling them to move on to their next experimental questions sooner;
−Removed: • Increases scale.
−Removed: Reliable, scalable software helps to remove analysis as a bottleneck as our customers plan larger and more ambitious experimental designs;
−Removed: • Expands the user base.
−Removed: While early adopters are more likely to have access to bioinformatics expertise, our software enables a broader range of customers to take advantage of our solutions;
−Removed: • Enables better understanding of our customers’ needs.
−Removed: By supplying analysis software for our customers, we gain much greater insight into their use cases, helping us to design future products that best meet their needs;
−Removed: • Enhances and accelerates product development.
−Removed: The software we ship to customers is the same software we use to develop and optimize our platforms and chemistry.
−Removed: This aligns us closely with the needs of our customers and reduces our time-to-market.
−Removed: The introduction of 10x Genomics Cloud Analysis enhances our ability to execute on, and bring value to our customers along, all of the dimensions enumerated above.
−Removed: Our product development approach
−Removed: The success of our products is founded on how we approach product development.
−Removed: Our employees are deeply scientifically oriented, having the relevant scientific expertise embedded not only within research and development, but also within the management team and throughout the company.
−Removed: We are ambitious and focus on fundamentals.
−Removed: We strive to solve big challenges to enable new fundamental biology and to build technological capabilities with potential for exponential impact.
−Removed: We work closely with our customers, many of whom are thought leaders in genomics and medicine, to identify future frontiers and unmet needs.
−Removed: Once we identify the correct opportunities, which we create through both organic development by our in-house teams and targeted acquisitions of technologies that will accelerate our ability to bring new products to researchers, we have the discipline to focus on execution and have a track record of bringing successful products to market.
−Removed: Multidisciplinary collaboration and technological innovation are central to our product development process.
−Removed: We have built teams with deep expertise across diverse disciplines including chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering.
−Removed: This multidisciplinary expertise forms the basis of our innovation engine, which allows us to introduce new products at a rapid pace as well as continuously launch improved versions of our existing products.
−Removed: Our solutions enable our customers to focus on biology by providing them with intuitive user interfaces and software.
−Removed: Our products guide customers through the workflow, from preparing samples, to reading sample information on a third-party sequencer, through analyzing and visualizing this information, to make obtaining biological answers as easy as possible.
−Removed: Our workflows operate with existing sequencers that are widely available in research settings.
−Removed: Our market opportunity
−Removed: According to industry sources, the worldwide life sciences research tools market totaled more than $60 billion in 2020.
−Removed: Our diverse products and solutions allow biologists to interrogate and understand biological systems at exceptional resolution and scale.
−Removed: Our focus on enabling a comprehensive view of biology, and not narrowly focusing on a particular analyte such as DNA alone, has produced products which we believe have broad applications and target numerous opportunities across different areas of life sciences research.
−Removed: Because we provide solutions to answer a broad diversity of biological questions, we view much of this total market as ultimately accessible to us.
−Removed: Areas in which our current solutions offer alternative or complementary approaches to existing tools represented a total opportunity of approximately $15 billion of the more than $60 billion global life sciences research tools market in 2020.
−Removed: This $15 billion opportunity includes flow cytometry, next generation sequencing, laboratory automation, microscopy and sample preparation, among other tools.
−Removed: In many cases, our current solutions offer alternative approaches to existing tools, where the advantages of our solutions can provide more precise answers to existing biological questions than existing tools and technologies.
−Removed: Our tools may also complement, enhance and enable new applications of these technologies.
−Removed: We believe we will compete for research spending within the life science research tools market and capture an increasing share of research budgets as our solutions deliver new capabilities, enable new applications and lead to new discoveries.
−Removed: We also expect to pursue additional opportunities that will further expand our opportunity, including new potential applications of our single cell, spatial and In Situ technologies in the future.
−Removed: We believe there is a large opportunity represented by the number of global academic labs.
−Removed: Based on our internal estimates, we believe there are more than 100,000 global academic labs available to us consisting of United States and international academic research labs, including those funded by the National Institutes of Health ("NIH"), government funding institutions and other privately funded institutions.
−Removed: In the United States alone, approximately 90,000 individual labs have applied for NIH funding over the past five years, and we estimate that more than 50,000 of these researchers work on projects that would benefit from adopting single cell and spatial genomics applications.
−Removed: In addition to customer labs, we believe a strong benchmark of the potential adoption of our solutions is the installed base of real-time polymerase chain reaction (“RT-PCR”) units, which is approximately 50,000 units globally.
−Removed: We also believe, based on industry sources, that there are over 15,000 next generation sequencers installed globally.
−Removed: While owners of next-generation sequencing instruments are one of several potential constituencies for buying our solutions, many of our customers do not own a sequencer and, as the number of cumulative instruments we have sold has grown, many of our customers have purchased multiple Chromium instruments.
−Removed: We believe that our opportunity for sales of our instruments is meaningfully larger than the installed base of next generation sequencers.
−Removed: Growth of our opportunity is also driven by a broad and increasing range of applications for our solutions.
−Removed: Our solutions can be used in many different applications, including basic biology, oncology and immuno-oncology, genetic disease, neurological disease, autoimmunity, infectious disease, the human microbiome and many others.
−Removed: In the “Century of Biology,” we believe that the mastery of biology will create advances and benefits for a broad and growing range of industries including broader segments of the healthcare industry and beyond.
−Removed: Our competitive strengths
−Removed: We believe our continued growth will be driven by the following competitive strengths:
−Removed: Our position as a leader in a large and growing market.
−Removed: Since launching our first product in mid-2015 through December 31, 2021, cumulatively we have sold 3,511 instruments and we serve thousands of researchers globally.
−Removed: We have fostered deep relationships with many key opinion leaders and as of December 31, 2021, our customers included all of the top 100 global research institutions as ranked by Nature in 2020 based on publications and all of the top 20 global biopharmaceutical companies by 2020 research and development spend.
−Removed: Our products are an important part of our customers’ workflow and a significant portion of them utilize more than one of our solutions.
−Removed: Our technologies have become a vital tool for biological research.
−Removed: To date, more than 3,300 peer-reviewed articles have been published based on data generated using our products.
−Removed: Our position as a leader in this market allows us to form deep partnerships with our customers who help us stay on the frontiers of biology, giving us insight on industry needs that inform our product strategy and providing us with a strong competitive advantage.
−Removed: Our proprietary technologies.
−Removed: Through multiple years of development, acquisition and in-licensing, we have amassed a core set of technologies and intellectual property rights that form the foundation of our growing suite of products and solutions.
−Removed: These technologies, including instruments, assays and software, combine a diverse set of disciplines, including chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering.
−Removed: Our technologies underlie features and performance that differentiate our products from the competition.
−Removed: Further, many of these technological elements can be utilized across multiple products, enabling us to leverage our existing infrastructure and investment when building future products, increasing the speed of product development and product performance.
−Removed: Worldwide we own or exclusively in-license over 460 issued or allowed patents and over 830 pending patent applications as of December 31, 2021.
−Removed: In addition to these owned and exclusively licensed patents and pending patent applications, we also license patents on a non-exclusive and/or territory restricted basis.
−Removed: Our intellectual property portfolio includes important patents and patent applications directed to single cell analysis, epigenomics, spatial analysis, in situ analysis and multi-omics.
−Removed: Our rigorous product development processes and scalable infrastructure.
−Removed: We have implemented a rigorous and systematic product development process by which our vision can be efficiently translated into commercial products.
−Removed: We develop our products over a set of defined phases delineated by validating multifunctional reviews, which ensure our teams remain focused on quality, efficiency and profitability.
−Removed: This process allows many highly focused teams to execute on separate product development efforts in parallel while drawing effectively on the resources and capabilities of the company.
−Removed: We have also built extensive technological and operational infrastructure to support the efficient execution of these teams.
−Removed: This infrastructure includes multiple technological investments across a range of areas, including custom barcoded gel bead production, microfluidic chip manufacturing, scalable high-performance computation and automated software productization and testing tools.
−Removed: This infrastructure can be drawn on to develop new products and improved versions of our existing products with high quality at a rapid pace.
−Removed: Our customer experience and broad commercial reach.
−Removed: We believe in providing our customers with a high-quality experience from start to finish:
−Removed: starting with a collection of validated methods for preparation of samples to be run on our systems and ending with extensive software to aid in analysis and visualization of the data generated.
−Removed: We have also built comprehensive product testing and quality control into our culture and processes to help guarantee the performance of our products in customer hands.
−Removed: As of December 31, 2021, we employed a commercial team of 417 full time employees.
−Removed: This includes an extensive and highly specialized customer service infrastructure with technical specialists covering multiple areas of expertise, including experimental biology, tissue analysis and handling and software.
−Removed: Many members of our sales and customer service teams have a PhD degree in the relevant scientific field.
−Removed: Both our sales and customer service teams help ensure our customers are successful in designing and executing their experiments and have a positive experience with our products.
−Removed: Our experienced multidisciplinary team .
−Removed: At 10x, we have built a multidisciplinary team with talent and expertise across a diverse set of areas such as chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering who are committed to identifying and addressing problems at the forefront of biology.
−Removed: We have supplemented our diverse technical experience by assembling an operational team with expertise in manufacturing, legal, sales, marketing, customer service and finance.
−Removed: We believe this confluence of talent from multiple disciplines at 10x allows us to stay ahead of our competitors by identifying highly impactful opportunities and building products and solutions that address these opportunities.
−Removed: Our growth strategy
−Removed: Our growth strategy includes the following key elements:
−Removed: Develop critical enabling technologies .
−Removed: Just as our past success is attributable to our innovative technologies, we believe that our future growth will be driven in large part by our significant continued investment in research and development.
−Removed: We aim to build new platforms, consumables and software that further our goals of interrogating, understanding and mastering biological systems at the needed resolution and scale.
−Removed: We prioritize innovations that meet large unmet market needs, such as measuring novel biological analytes with key functional impact at the single cell level or with spatial context.
−Removed: We expect that these investments in research and development will allow us to increase our penetration of our accessible markets.
−Removed: Expand our sales of our Chromium instruments .
−Removed: Since our commercial launch in mid-2015 through December 31, 2021, cumulatively we have sold 3,511 instruments and serve thousands of researchers globally.
−Removed: Utilizing our multi-channel sales and distribution infrastructure, we will continue to engage with researchers to increase our sales of Chromium instruments.
−Removed: We will target new customers in addition to expanding the number of instruments within institutions that have already recognized the significant value of our technology.
−Removed: A portion of our current laboratory customers do not yet own a Chromium instrument, but rather gain access to one of our instruments through an adjacent lab or core facility within the institution.
−Removed: These customers are substantial and easily accessible and therefore represent an opportunity for future instrument sales.
−Removed: We also intend to expand our existing geographic reach, both directly and through distributors.
−Removed: Strengthen use and adoption of our consumables .
−Removed: Our instruments are designed to be used exclusively with our consumables.
−Removed: This closed system generates recurring revenue from consumables tied to each instrument we sell.
−Removed: We plan to drive wider adoption of our products within the workflows of our existing customers.
−Removed: For example, although many biopharmaceutical companies use our products in early drug discovery phases from target identification to validation and across multiple sites, we believe that as our applications are increasingly incorporated into later stages in the drug development process, the amount of our consumables used will grow.
−Removed: We have built a dedicated global strategic sales, marketing and business development team to support the adoption cycle by biopharmaceutical companies.
−Removed: We have also added new instruments to our Chromium instrument lineup which are aimed addressing new customer use cases and driving higher consumable revenue growth.
−Removed: For instance, our Chromium Connect instrument, launched in 2020, automates manual processes to reduce bottlenecks and encourage increased adoption.
−Removed: Additionally, our Chromium X instrument, launched in 2021, enables expansion of single cell studies to routine million cell experiments.
−Removed: We also plan to demonstrate new applications using our current solutions, including applications making synergistic use of multiple solutions.
−Removed: Identify the most relevant technologies, create or acquire such technologies and develop them into new products .
−Removed: Over the years, we have developed, acquired or in-licensed a core set of technologies and associated intellectual property rights across a broad range of emerging areas within biology and life sciences.
−Removed: The ability to identify these core technologies and capabilities has complemented our internal product development process and enhanced our growing suite of products and solutions.
−Removed: We will continue to identify and acquire or in-license technologies and intellectual property rights that accelerate the development of new features and products or complement our existing features, products and technologies.
−Removed: For instance, we acquired Epinomics, Inc.
−Removed: (“Epinomics”) and Spatial Transcriptomics Holdings AB (“Spatial Transcriptomics”) in 2018, obtaining technology and intellectual property that formed the foundation of our ATAC-seq assay and Visium platform, respectively.
−Removed: We acquired ReadCoor, Inc.
−Removed: ("ReadCoor") and CartaNA AB ("CartaNA") in 2020, obtaining intellectual property, key technology advances, and deep talent and expertise in the emerging In Situ field and forming the foundation for our forthcoming Xenium platform.
−Removed: Additionally, in January 2021 we acquired Tetramer Shop ApS, a developer and provider of reagents for precise monitoring of antigen-specific T cells in research and development, enabling us to strengthen our efforts in immunology.
−Removed: We expect to commercialize this technology with our BEAM-T product in 2022.
−Removed: Promote our platforms as the standard for single cell, spatial and in situ analysis .
−Removed: We believe many key opinion leaders have recognized our Chromium platform as the standard for single cell analysis.
−Removed: One of our strategies is to broaden this recognition and promote the breadth of scientific achievements enabled by our products.
−Removed: To date, more than 3,300 peer-reviewed articles have been published using data generated by our portfolio of Chromium and Visium solutions.
−Removed: We believe further research and discoveries will unfold as our solutions are utilized as the global standard and that our forthcoming Xenium platform, based on in situ technology, could be impactful on how biological research and clinical assays will be conducted in the future.
−Removed: Our products and technology
−Removed: Our products are integrated solutions comprised of instruments, consumables and software.
+Added: Our platforms
+Added: Our platforms are integrated solutions comprised of instruments, consumables and software.
They are built with our expertise in chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering.
−Removed: Our products begin with a researcher’s sample (such as a collection of thousands to millions of cells or a slice of FFPE tissue) and perform high-
−Removed: throughput barcoding to construct libraries that are compatible with standard sequencers.
−Removed: Our proprietary software then provides turn-key analysis pipelines and intuitive visualization tools that allow researchers to easily interpret the biological data from the samples.
−Removed: A summary of our solutions follows below.
+Added: All of our products begin with a researcher’s sample (such as a collection of thousands to millions of cells or a slice of fresh frozen or FFPE tissue).
+Added: Our Chromium platform performs high-throughput barcoding to construct libraries that are compatible with standard third-party sequencers.
+Added: Our Visium platform allows researchers to combine spatially resolved whole transcriptome measurements across tissue sections with a high-resolution image.
+Added: Thousands of unique, arrayed barcodes that represent a spatial location allow for analytes to be captured from tissue, spatially barcoded and then mapped back to their original tissue location after sequencing.
+Added: Our Xenium platform includes the Xenium Analyzer, a fully automated instrument that integrates sample handling, liquid handling and imaging.
+Added: In this workflow, targeted probes are hybridized to tissue sections on Xenium slides, which are then processed on our Xenium Analyzer.
+Added: Sequencing is not required.
+Added: Our proprietary software then provides turn-key analysis pipelines and intuitive visualization tools for all of our platforms that allows researchers to easily interpret the biological data from the samples.
Our Chromium platform
−Removed: Our Chromium platform, which includes our Chromium Controller, Chromium X Series and Chromium Connect Instruments, microfluidic chips and related consumables, enables high-throughput analysis of individual biological components.
+Added: Our Chromium platform, which includes our Chromium X Series, Chromium Connect and legacy Chromium Controller instruments, microfluidic chips and related consumables, enables high-throughput analysis of individual biological components.
The Chromium instruments serve as precisely engineered reagent delivery systems that divide a sample into individual components in up to a million or more partitions, enabling large numbers of parallel micro-reactions.
The Chromium platform can be used to partition not only single cells, but also other biological materials such as cell nuclei and DNA molecules.
−Removed: The large numbers of partitions generated using our Chromium products can be used for analyzing samples at high resolutions and at large scales.
+Added: The large numbers of partitions generated using our Chromium products can be used for analyzing samples at high resolution and on
+Added: massive scale.
We pair a partitioned sample with our proprietary gel beads bearing barcodes that allow researchers to uniquely identify the contents of each partition and distinguish them from contents of other partitions.
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We collectively refer to our partitioning and barcoding technologies as our GemCode technology.
−Removed: Our Chromium Controller, Chromium X and iX, Chromium Connect and microfluidic chips .
+Added: Our Chromium X and iX, Chromium Connect and microfluidic chips .
Our Chromium consumables run on our Chromium instruments.
−Removed: Our Chromium Controller and Chromium iX instruments are capable of running our Low Throughput and Standard Throughput consumables.
+Added: Our Chromium iX instrument is capable of running our Low Throughput and Standard Throughput consumables.
Our Chromium X instrument is capable of running Low, Standard and High Throughput consumables.
Customers are able to upgrade their Chromium iX to run Low, Standard and High Throughput consumables via firmware upgrade.
−Removed: We have designed our instruments to be widely accessible to researchers with list prices of $35,000, $60,000 and $95,000 for the Chromium Controller, Chromium iX and Chromium X, respectively, and each of these instruments has a form factor that easily fits on a standard laboratory bench.
+Added: We have designed our instruments to be widely accessible to researchers and each of these instruments has a form factor that easily fits on a standard laboratory bench.
Our Chromium instruments operate exclusively with our microfluidic chips, which are highly engineered single-use devices that process samples and reagents.
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The loaded chip is inserted into the Chromium instrument, which facilitates the generation of GEMs that contain sample and gel beads.
−Removed: Our Chromium Connect product is a high-throughput version of our Chromium Controller instrument that incorporates liquid handling robotics to automate our workflow and can be utilized with our Single Cell Gene Expression and Single Cell Immune Profiling solutions.
−Removed: Our Gel Beads .
−Removed: Within each GEM, the sample is co-encapsulated with one of our proprietary gel beads which are designed to contain a unique, identifying DNA barcode for subsequent sequencing and analysis.
−Removed: Our gel beads, which we manufacture in-house using proprietary methods, incorporate barcoded DNA molecules that are designed to react with the sample inside each GEM.
−Removed: The GEMs act as individual reaction vessels to generate barcoded molecules.
−Removed: We have developed various molecular assays that can be used to perform barcoding reactions with different types of biological analytes—for example, our proprietary GEM-RT assay incorporates sequences of mRNA into barcoded molecules.
−Removed: Once those barcoded molecules are generated inside individual GEMs, the GEMs can be broken and their contents pooled to generate libraries that can be analyzed by widely available third-party sequencers.
−Removed: Critically, because different GEMs have different DNA barcodes, each sequencing read can be traced back to its GEM of origin, allowing identification of the biological source or context of the contents of the GEM.
−Removed: This barcoding paradigm enables multiplexing across very large numbers of cells or other biological material.
−Removed: Key GemCode advantages .
−Removed: Our GemCode technology has a number of technological advantages over alternative tools.
−Removed: For example, our gel beads are composed of proprietary materials that permit their incorporation into GEMs at high efficiency.
−Removed: This efficiency increases the number of partitions that include one and only one barcoded gel bead and avoids loss of information from samples that are not paired with barcodes.
−Removed: Furthermore, the chemical structure of our gel beads allows them to not only encapsulate hundreds of millions of copies of DNA barcode oligonucleotides, but also permit their controlled release at precise times during our workflow.
−Removed: Similarly, our microfluidic chips are engineered to highly precise dimensions and consist of materials that optimize the partitioning of biological materials into GEMs.
−Removed: Such features enable our Chromium platform to provide a combination of superior performance characteristics for single cell analyses:
+Added: Our Chromium Connect product is an automated Chromium instrument that incorporates liquid handling robotics to automate our workflow and can be utilized with our Single Cell Gene Expression and Single Cell Immune Profiling solutions.
+Added: The following are key advantages of our Chromium platform:
• High cell throughput :
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Our Standard Throughput Single Cell Gene Expression and Immune Profiling solutions, on the other hand, have cell throughputs of up to 80,000 cells per run using one microfluidic chip which increases the likelihood of finding a copy of the disease-causing cell.
−Removed: With the launch of our High Throughput Single Cell Gene Expression and Immune Profiling solutions, we have increased cell throughput and enable analysis of up to 320,000 cells per microfluidic chip.
+Added: Our High Throughput Single Cell Gene Expression and Immune Profiling solutions enable analysis of up to 320,000 cells per microfluidic chip.
+Added: With the launch of our Single Cell Gene Expression Flex solution, we have increased cell throughput and enable analysis of up to 1,000,000 cells per microfluidic chip.
• High cell capture rate :
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A high cell capture rate is important in many cases where researchers start with only a limited number of rare cells, such as a tumor biopsy from a patient.
−Removed: Our Single Cell Gene Expression and Immune Profiling solutions, for example, have typical cell capture rates of about 65%, which is significantly higher than those achieved by many competing solutions.
+Added: Our single cell solutions have typical cell capture rates of about 65%, which is significantly higher than those achieved by many competing solutions.
• Low doublet rate :
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Researchers seek products with low doublet rates.
−Removed: Our Single Cell Gene Expression, ATAC and Immune Profiling solutions, for example, have doublet rates of less than 1% per 1,000 cells.
−Removed: Our Chromium platform currently provides researchers with solutions in four major application areas:
+Added: Our single cell solutions have doublet rates of less than 1% per 1,000 cells.
+Added: Our Chromium platform currently provides researchers with the following solutions:
Single Cell Gene Expression
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This approach enables customers to identify and characterize rare cell types in a population of cells, characterize cell populations without prior knowledge of cell subtypes or cell markers, define novel cell types and cell states, discover new biomarkers for specific cell populations and analyze and understand cellular heterogeneity and its effects on biological systems.
−Removed: For this solution, customers run their samples of interest on the Chromium Controller, Chromium X Series or Chromium Connect to generate GEMs containing single cells and prepare single cell libraries using our reagents.
−Removed: Researchers can sequence these single cell libraries on compatible third-party sequencers, analyze their data using our Cell Ranger analysis pipeline software and visualize their data using our Loupe Cell Browser software.
+Added: For this solution, customers run their samples of interest on Chromium X Series or Chromium Connect instruments, or on legacy Chromium Controller instruments, to generate GEMs containing single cells and prepare single cell libraries using our reagents.
+Added: Researchers can sequence these single cell libraries on standard third-party sequencers, analyze their data using our Cell Ranger analysis pipeline software and visualize their data using our Loupe Cell Browser software.
The browser displays a visual representation of the data in which cells having similar gene expression profiles are colored and clustered together.
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Major subpopulations were identified based on gene markers that are enriched in each class.
−Removed: Our Single Cell Gene Expression solution uses our proprietary biochemistry, GEM-RT, to capture mRNA molecules with high sensitivity.
+Added: Our Chromium Single Cell Gene Expression solution uses our proprietary biochemistry, GEM-RT, to capture mRNA molecules with high sensitivity.
Sensitivity is the number of different mRNA transcripts that can be detected.
Higher sensitivities are required to detect mRNA molecules that are present in low abundance in a cell.
−Removed: Our latest version of this solution uses a new GEM-RT biochemistry that now has an increased sensitivity of up to 8,500 unique transcripts per cell.
−Removed: Furthermore, our Single Cell Gene Expression solution can be used with our Feature Barcode technology to simultaneously measure multiple analytes in the same cells.
+Added: Our latest version of this solution uses our GEM-RT biochemistry that has an increased sensitivity of up to 8,500 unique transcripts per cell.
+Added: Furthermore, our Chromium Single Cell Gene Expression solution can be used with our Feature Barcode technology to simultaneously measure multiple analytes in the same cells.
Our Feature Barcode is highly customizable, allowing our customers to add a barcode to any biological feature they want to analyze in conjunction with gene expression and other biological data.
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• Measure a set of CRISPR genetic perturbations that have been applied to a cell simultaneously with the resulting changes to gene expression and/or surface protein characterization, allowing users to interrogate the impact of actively perturbing many different aspects of a biological system in a massively parallel fashion.
−Removed: Our Single Cell Gene Expression solution, along with our other single cell solutions, are currently used by the Human Cell Atlas (“HCA”).
−Removed: The HCA is an international consortium of prominent genomics researchers that has emerged as the first and largest project aiming to develop reference maps for all cell types in all tissues of the human body.
−Removed: In 2017, we announced a collaboration with the HCA to enable pilot research projects.
−Removed: Under the terms of this collaboration, we provide members of the HCA consortium with discounts on our instruments and consumables.
−Removed: Sales to members of the HCA consortium accounted for less than 10% of our revenue for the years ended December 31, 2021 and December 31, 2020.
−Removed: In much the same way that the standardized reference human genome generated by the Human Genome Project in 2003 paved the way for significant leaps in genomics, we believe that creation of a standardized reference of human cell types is critical for future advances.
−Removed: We believe that our partnership with the HCA is a recognition of the quality of our products and may accelerate their adoption by the wider research community.
−Removed: To date, more than 3,300 peer-reviewed scientific publications have been published using data generated by our Single Cell Gene Expression solution with the top research areas being developmental biology, immunology and oncology.
+Added: To date, more than 3,400 peer-reviewed scientific publications have been published using data generated by our Chromium Single Cell Gene Expression solution with the top research areas being oncology, immunology and developmental biology.
This body of work is yielding significant insights into many different areas of biology and disease.
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Through this work, the authors clarified the expression patterns of key genes responsible for SARS-CoV-2 infection of human cells throughout the body, providing the most detailed view for where SARS-CoV-2 could infect human cells, which suggested important implications for viral transmissibility.
−Removed: This analysis highlighted the forward-thinking importance of the Human Cell Atlas consortium efforts to use single-cell gene expression, supported by us to extensively catalogue all of the cells present throughout every tissue and organ in the human body as a foundation for future understanding of critical human diseases.
+Added: This analysis highlighted the forward-thinking importance of the Human Cell Atlas consortium efforts to use single cell gene expression supported by us to extensively catalog all of the cells present throughout every tissue and organ in the human body as a foundation for future understanding of critical human diseases.
Subsequent single cell gene expression studies throughout 2020 built upon this foundation to identify the cellular expression of additional genes and molecular regulatory mechanisms required for SARS-CoV-2 infection, differences in cellular immune responses that correlate with severity of COVID-19 and to develop human cell culture, non-human animal and human organoid models of infection to enable the rapid pre-clinical study of treatments for this disease.
+Added: Single Cell Gene Expression Flex
+Added: In 2022, we introduced our Chromium Single Cell Gene Expression Flex solution.
+Added: Like our Chromium Single Cell Gene Expression solution, Flex provides customers with the ability to measure the transcriptome of single cells, revealing gene activity and networks on a cell-by-cell basis.
+Added: Single cell RNA sequencing is increasingly being used to profile larger numbers of samples, corresponding to cohorts of patients or different perturbations, increasing the importance of an efficient and scalable workflow.
+Added: Chromium Single Cell Gene Expression Flex works on samples fixed with paraformaldehyde (PFA), which allows samples to be collected, shipped to a central location and analyzed without sacrificing integrity or data quality, creating new possibilities for sample accessibility, throughput and batched analysis.
+Added: This advanced chemistry also brings single cell profiling to FFPE tissue, expanding the range of accessible sample types.
+Added: Customers can fix fresh samples at the point of collection to lock in biological states and preserve fragile cells or use this solution to access archived samples.
+Added: We expect that this solution will be especially suited for translational and clinical labs where fragile samples or time constraints would otherwise preclude single cell analysis.
+Added: Chromium Single Cell Gene Expression Flex allows for profiling up to 1,000,000 fixed single cells at once with a scalable workflow.
+Added: Chromium Single Cell Gene Expression Flex can be used exclusively with our Chromium X Series instruments to generate GEMs.
+Added: Prior to GEM generation, cells are fixed and permeabilized and can be safely stored or transported without compromising data quality.
+Added: When commencing the experiment using Chromium Single Cell Gene Expression Flex, samples are hybridized to probe sets and may be processed individually (singleplex workflow) or pooled with up to 16 samples in a single lane of a 10x chip (multiplex workflow).
+Added: During GEM generation the probe sets are ligated and extended to incorporate unique barcodes.
+Added: Sequencing libraries are then prepared, sequenced and analyzed using our Cell Ranger and Loupe Browser software tools.
Single Cell Immune Profiling
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T-cells and B-cells can generate an immense diversity of receptors that are each specific to a different potential antigen, making it possible for the human body to recognize nearly any conceivable antigen.
−Removed: Our Single Cell Immune Profiling solution enables researchers to study these receptor molecules at the single cell level in conjunction with the transcriptome of the immune cell.
+Added: Our Chromium Single Cell Immune Profiling solution enables researchers to study these receptor molecules at the single cell level in conjunction with the transcriptome of the immune cell.
Through the use of our solutions, researchers can measure both the T-cell or B-cell receptors while also determining whether the cell has been activated to attack its target or is quiescent and waiting for a threat to emerge.
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This paired receptor information is unavailable from traditional bulk approaches for analyzing immune cells and is critical as it is the pair of receptors that defines the targets of each immune cell.
−Removed: By enabling paired immune receptor and transcriptome analysis in massive numbers of immune cells, our Single Cell Immune Profiling solution sheds insight on the clonality, diversity and cellular context of the immune repertoire.
−Removed: The workflow of this solution, which is similar to that of the Single Cell Gene Expression solution, utilizes our Chromium Controller, Chromium X Series or Chromium Connect to generate GEMs, followed by single cell library preparation and sequencing.
−Removed: In contrast to Gene Expression, our Single Cell Immune Profiling solution uses a different biochemistry that obtains sequence information from the 5’ end of mRNA molecules, rather than their 3’ end.
+Added: By enabling paired immune receptor and transcriptome analysis in massive numbers of immune cells, our Chromium Single Cell Immune Profiling solution sheds insight on the clonality, diversity and cellular context of the immune repertoire.
+Added: The workflow of this solution, which is similar to that of the Chromium Single Cell Gene Expression solution, utilizes our Chromium X Series, Chromium Connect or legacy Chromium Controller to generate GEMs, followed by single cell library preparation and sequencing.
+Added: In contrast to Gene Expression, our Chromium Single Cell Immune Profiling solution uses a different biochemistry that obtains sequence information from the 5’ end of mRNA molecules, rather than their 3’ end.
This biochemistry allows researchers to capture the more information-rich regions of immune receptor transcripts.
−Removed: Our Single Cell Immune Profiling solution also includes a step of enriching for immune receptor transcripts using specific primers to create an immune-specific library that can be sequenced separately from gene expression.
+Added: Our Chromium Single Cell Immune Profiling solution also includes a step of enriching for immune receptor transcripts using specific primers to create an immune-specific library that can be sequenced separately from gene expression.
We have also developed specialized pipelines within our Cell Ranger software and a specialized visualization software, Loupe V(D)J Browser, for visualizing the paired immune receptor information derived from this product.
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This capability allows researchers to determine both the receptor sequences of individual immune cells as well as an antigen that the receptor targets and makes this analysis practical to perform for millions of immune cells.
−Removed: We believe that the capability to understand immune receptor-antigen interactions at a high-throughput single cell level is tremendously valuable for elucidating the rules of immune cell targeting and can be used to understand disease and identify leads for immunotherapies.
−Removed: We believe our technology can assist researchers in constructing an immune map of receptor-antigen targeting rules.
−Removed: Such a map would allow for the prediction of the antigens recognized by a given receptor, or conversely, the prediction of receptors that bind to a given antigen.
−Removed: Due to the large number of potential receptor sequences and the large number of possible antigens, researchers previously assumed that computational prediction of the cognate antigen from receptor sequence alone would be impractical.
−Removed: However, recent work demonstrated that T-cell receptor sequences that recognize the same antigen shared enough sequence features that a computational prediction framework for mapping T-cell receptors to antigens is feasible.
−Removed: We believe that our Single Cell Immune Profiling Solution combined with Feature Barcode will enable extending this work at far higher scales.
−Removed: In 2022, we expect to make our Barcode Enabled Antigen Mapping (BEAM) Solution commercially available .
−Removed: We anticipate that our BEAM-Ab and BEAM-T technologies will provide an end-to-end solution for the high-throughput discovery of antibodies and T-cell receptors respectively against multiple antigens in as quickly as one week.
−Removed: We anticipate that this product will be especially suited for biotech and pharmaceutical companies and we expect the solution to include tailor made software designed to process and analyze these rich data sets.
+Added: We believe that the capability to understand immune receptor-antigen interactions at a high-throughput single cell level is
+Added: tremendously valuable for elucidating the rules of immune cell targeting and can be used to understand disease and identify leads for immunotherapies and to assist researchers in constructing an immune map of receptor-antigen targeting rules.
+Added: In 2022, we launched our Barcode Enabled Antigen Mapping (BEAM) solution, to be used in combination with our Chromium Single Cell Immune Profiling solution.
+Added: BEAM enables rapid discovery of tens to hundreds of antigen-reactive B-cell receptors (BEAM-Ab) and T-cell receptors (BEAM-T) against multiple antigens from a single sample in as quickly as one week.
+Added: We anticipate that this product will be especially suited for biotech and pharmaceutical companies and the solution includes tailor made software designed to process and analyze these rich data sets.
Single Cell ATAC
Our Chromium Single Cell ATAC solution enables customers to understand the epigenetic state—including how the genome and its surroundings are modified to “open” and “closed” states, affecting how genes are regulated—in up to millions of cells.
−Removed: While our Single Cell Gene Expression solution answers the “what” of what makes two cells different from each other, our Single Cell ATAC solution answers the “how.” These two products are highly complementary and can be used as a powerful combination to understand both the cause and effect of gene regulation.
+Added: While our Chromium Single Cell Gene Expression solution answers the “what” of what makes two cells different from each other, our Chromium Single Cell ATAC solution answers the “how.” These two products are highly complementary and can be used as a powerful combination to understand both the cause and effect of gene regulation.
ATAC-seq stands for “Assay for Transposase Accessible Chromatin using sequencing.” This technique uses an engineered transposase enzyme to insert nucleic acids tags into the genome while also excising the tagged sequences from its surroundings.
ATAC-seq is based on the fact that the transposase enzyme will preferentially tag and excise regions of the genome that have an “open” chromatin state that is unimpeded by proteins bound to genomic DNA.
−Removed: The tagged sequences can be sequenced to infer
−Removed: genomic regions of increased chromatin accessibility as well as map regions that are bound by transcription factor proteins responsible for regulating gene expression.
+Added: The tagged sequences can be sequenced to infer genomic regions of increased chromatin accessibility as well as map regions that are bound by transcription factor proteins responsible for regulating gene expression.
ATAC–seq was pioneered by researchers at Stanford University and intellectual property rights directed to ATAC-seq are exclusively licensed to us.
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Our Single Cell ATAC solution uses the ATAC-seq assay in conjunction with our Chromium platform to create a product for high-throughput epigenetic interrogation at single cell resolution.
−Removed: In the workflow, users treat cell nuclei with transposase enzyme and then use our Chromium Controller to encapsulate these nuclei in GEMs.
+Added: In the workflow, users treat cell nuclei with transposase enzyme and then use our Chromium instrument to encapsulate these nuclei in GEMs.
The tagged sequences from the nuclei are barcoded inside GEMs and then processed to generate sequencing libraries.
−Removed: Sequencing reads are analyzed using our Cell Ranger ATAC software, and visualized using our Loupe Cell Browser, which has been especially configured to display epigenetic data.
+Added: Sequencing reads are analyzed using our Cell Ranger ATAC software and visualized using our Loupe Cell Browser, which has been specially configured to display epigenetic data.
The following visualization is an example of plots showing open chromatin around genes that are specifically associated with certain cell types.
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Plots show aggregate chromatin accessibility profiles for each cluster at several marker gene loci.
−Removed: Our Single Cell ATAC solution has been adopted by a number of key opinion leaders.
+Added: Our Chromium Single Cell ATAC solution has been adopted by a number of key opinion leaders.
In one example, researchers used a combination of single cell transcriptome profiling and single cell ATAC-seq to identify enhancer elements that mark specific sub-classes of cells in the mouse brain.
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Previously, researchers would profile these two modalities separately using our Single Cell Gene Expression solution and Single Cell ATAC solution, and computationally infer related cell types between the two datasets.
−Removed: However, with our recently introduced Single Cell Multiome ATAC+Gene Expression solution, it is now possible to directly measure both modalities in the same single cell, providing valuable insights into how the epigenetic landscape in a cell (the “input”) directly impacts downstream gene expression (the “output”).
+Added: However, with our Single Cell Multiome ATAC+Gene Expression solution, it is now possible to directly measure both modalities in the same single cell, providing valuable insights into how the epigenetic landscape in a cell (the “input”) directly impacts downstream gene expression (the “output”).
Our Single Cell Multiome ATAC+Gene Expression solution is similar in workflow to our Single Cell Gene Expression and Single Cell ATAC products on the Chromium platform.
−Removed: In the workflow, users treat cell nuclei with transposase enzyme and then use our Chromium Controller to encapsulate these nuclei in GEMs.
+Added: In the workflow, users treat cell nuclei with transposase enzyme and then use our Chromium instrument to encapsulate these nuclei in GEMs.
The tagged DNA sequences and the mRNA from the nuclei are barcoded inside GEMs and then processed to generate gene expression and ATAC sequencing libraries.
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The following visualization is an example of how chromatin accessibility from ATAC data can be linked with gene expression data for inferring regulatory interactions in cells:
−Removed: This product launched in the third quarter of 2020 and has been rapidly adopted by major academic institutions, including a study presented at the Opening Plenary session of the American Association for Cancer Research (AACR) Annual Meeting in 2020.
+Added: This product has been adopted by major academic institutions and powered a study presented at the Opening Plenary session of the American Association for Cancer Research (AACR) Annual Meeting in 2020.
In addition to applications in oncology, researchers are also applying the assay to neuroscience, including understanding the genetic architecture of neuropsychiatric diseases, and immunology, for understanding T-cell exhaustion during immunotherapy.
+Added: Sample preparation solutions .
+Added: In 2022, we launched our Nuclei Isolation kit, our first offering to help ease the sample preparation process.
+Added: This solution provides a simple, scalable workflow to make frozen tissues and previously challenging sample types more accessible for routine single cell analysis.
+Added: Many samples which may be biobanked or are not amenable to fresh processing require nuclei isolation for use in single cell sequencing.
+Added: Nuclei isolation is also necessary to obtain additional layers of cellular information, such as chromatin accessibility.
+Added: Previously available methods for nuclei isolation from frozen tissue include complex, low-throughput and time-consuming protocols, expensive instruments for sorting and debris removal and the need to optimize workflows for each tissue.
+Added: Our Chromium Nuclei Isolation kit, specifically designed for use with our single cell assays, streamlines nuclei isolation workflows, ensuring reliable assay performance for gene expression or epigenetic studies with little to no optimization for most tissues.
Our Visium platform
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Understanding the spatial relationship of the biological analytes in tissues may hold the key to unlocking the underlying causes and identifying cures for such diseases.
−Removed: Our Visium products are based on technology that we acquired from Spatial Transcriptomics in 2018.
+Added: Our Visium products are based in part on technology that we acquired from Spatial Transcriptomics in 2018.
Spatial Transcriptomics utilized arrays having specialized probes on their surfaces that are encoded with the spatial position of the probe.
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This barcoded material encodes the spatial information that was contained in the probes.
−Removed: Users then pool the material from the array and follow a protocol to create libraries of molecules that can be sequenced using a standard sequencer.
+Added: Users then pool the material from the array and follow a protocol to create libraries of molecules that can be sequenced using a standard third-party sequencer.
After sequencing, analysis software assigns each sequencing read to its spatial position of origin, aligning with a morphological stain of the tissue section.
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Our Visium Spatial Gene Expression product has significant improvements over the Spatial Transcriptomics product, including increased spatial resolution, increased gene sensitivity, a simpler workflow, compatibility with both hematoxylin and eosin (H&E) and immunofluorescence stains, and fully developed analysis and visualization software.
−Removed: In 2021, we launched Visium Spatial Gene Expression for FFPE which featured an entirely new chemistry enabling Visium to be applied to FFPE tissues with similarly high sensitivity and the same spatial resolution as fresh frozen samples.
−Removed: We intend to continuously innovate to provide enhanced resolution, performance, throughput and efficiency for our existing Visium Spatial Gene Expression product and we also intend to develop additional Visium spatial products using our other assays which, analogously to the Chromium platform, allow spatial interrogation of a broader range of biological analytes including DNA, immune molecules, epigenetics and protein.
+Added: We launched the Visium Spatial Proteogenomics solution providing the capability of combining whole transcriptome analysis and immunofluorescence protein detection within the same tissue section in 2020.
+Added: In 2021, we launched Visium Spatial Gene Expression for FFPE which featured an entirely new probe-based chemistry enabling Visium to be applied to FFPE tissues with similarly high sensitivity and the same spatial resolution as fresh frozen samples.
+Added: In 2022, we launched the Visium CytAssist, an instrument designed to simplify the Visium solution workflow by facilitating the transfer of transcriptomic probes from standard glass slides to Visium slides.
+Added: The Visium CytAssist is a compact, benchtop instrument that enables spatial profiling insights with broadest sample access, streamlined workflow logistics allowing the use of pre-sectioned tissues and pre-stained samples with the Visium workflow in both FFPE and fresh frozen samples.
+Added: Depending on the sample type, sectioning, sample preparation, staining, and hematoxylin and eosin (H&E) or immunofluorescent (IF) imaging take place on a standard glass slide in the Visium CytAssist workflow.
+Added: After probe hybridization, two standard glass slides and a two capture area Visium gene expression slide are placed in the CytAssist instrument so that the tissue sections on the standard slides can be aligned on top of the two Visium capture areas.
+Added: Within the instrument, a brightfield image is captured to provide spatial orientation for data analysis, followed by permeabilization of the tissue and transfer of transcriptomic probes to the Visium gene expression slide.
+Added: The remaining steps, starting with probe extension, follow the standard Visium for FFPE workflow outside of the instrument.
+Added: Data is visualized using our software tools.
+Added: We intend to continuously innovate to provide enhanced resolution, performance, throughput and efficiency for our existing Visium Spatial Gene Expression products and we also intend to develop additional Visium spatial products using our other assays which, analogous to the Chromium platform, allow spatial interrogation of a broader range of biological analytes including DNA, immune molecules, epigenetics and proteins.
Our Xenium platform
−Removed: Our forthcoming Xenium platform for in situ analysis is being designed to give scientists the ability to not only locate and type cells in their tissue context, but also to address a variety of specific questions based on previous knowledge of their sample often discovered using our Chromium and Visium platforms.
+Added: Our Xenium platform for in situ analysis is designed to give scientists the ability to not only locate and type cells in their tissue context, but also to address a variety of specific questions based on previous knowledge of their sample often discovered using our Chromium and Visium platforms.
In situ is a Latin expression that means “in the original place." In situ analysis is used to describe a method to detect and analyze RNA and protein molecules right where they are within the tissue, without the need to extract or capture them.
−Removed: Based on our internal research and development and the acquisitions of ReadCoor and CartaNA, we expect our Xenium platform to be a complete end-to-end solution, including a robust instrument, consumables and software.
−Removed: We anticipate it will be applicable to both fresh frozen and FFPE samples and have a menu of tissue-specific and research-specific gene panels along with the ability to design custom gene sets.
−Removed: We expect the instrument to come with onboard analysis capabilities to process image data, localize RNA signals and perform secondary analysis.
−Removed: We anticipate that customers will also be able to easily transfer data from the instrument and perform visualization and further analysis with 10x-provided software or other tools of their choice.
−Removed: Our analysis and visualization software
−Removed: Our software is a fundamental part of our integrated solutions and is comprised of two parts, analysis and visualization.
−Removed: Our analysis pipeline software tools, including Cell Ranger and Space Ranger, take raw sequencing data as input and transform them into biologically meaningful results.
−Removed: Customers can further analyze these results in their own or third-party tools, or take them into our Loupe family of visualization software tools, which allow users to draw insights using an intuitive user interface without writing code.
−Removed: Our analysis and visualization software is generally available to researchers free of charge, so as to accelerate the adoption of our products and software as a standard for genome, single cell and spatial analysis.
−Removed: In 2021, we launched 10x Genomics Cloud Analysis, which makes it even easier for new 10x customers to get started, and for our advanced users to scale to larger and more complex experiments.
−Removed: We believe that the main factors that differentiate our software include:
−Removed: • Ease of installation and use.
−Removed: Much of the software typically used in bioinformatics analysis requires substantial programming expertise to use and even just to install.
−Removed: We invest substantial effort in making our software both easy to install and use, so researchers can focus on their experiments rather than installation requirements.
−Removed: The 10x Genomics Cloud takes that one step further.
−Removed: • Advanced algorithms and methods.
−Removed: Our software makes the latest analytical methods easily accessible to researchers and we are constantly working to improve our software’s ability to realize the maximum value and benefit of the data produced by our chemistries and platforms.
−Removed: • Scalable from workstation to cluster to cloud.
−Removed: A robust, common architecture underlying our software tools gives researchers maximum flexibility to run our software on-premises on individual workstations or servers, on large high-performance compute clusters and in private and public clouds.
+Added: Based on our internal research and development and the acquisitions of ReadCoor and CartaNA, our Xenium platform is a complete end-to-end solution including a robust instrument, consumables and software.
+Added: The Xenium Analyzer instrument, which we began shipping in 2022, is designed for fully automated high-throughput analysis of cells in their tissue environment.
+Added: The end-to-end solution includes pre-designed, validated panels and analysis tools for visualizing and studying spatial patterns of expression.
+Added: Xenium In Situ detects and preserves the cellular localization of RNA targets directly in a fresh frozen or FFPE tissue section without the need for conventional sequencing.
+Added: This provides researchers with a detailed map of gene expression patterns without
+Added: sacrificing resolution or target number.
+Added: Xenium uses circularizable probes specific to target transcripts followed by enzymatic amplification to create a target for fluorescent probe hybridization.
+Added: On the Xenium Analyzer, microscope images of the tissue detect the location of each fluorescent probe, which is then removed.
+Added: Successive rounds of fluorescent probe hybridization, imaging and removal creates a unique optical signature that reveals the identity of the RNA at a location within each cell of a tissue.
+Added: In the future, we expect that Xenium will allow the detection of both RNA and protein in the same tissue section, revealing complex and nuanced expression patterns.
+Added: Our Xenium consumables consist of a menu of curated, validated and fit-for-purpose gene panels along with the ability to design custom gene sets.
+Added: Our initial panels include a Human Breast Gene Expression Panel for high-resolution cell typing of breast tissues and characterization of breast cancer disease states, including tumor microenvironments, and a Mouse Brain Gene Expression Panel for high-resolution cell typing of mouse brain tissue.
+Added: The panels were designed using single cell datasets with direct customer input and the genes were chosen to target cell types and cell states for each respective tissue type.
+Added: Each panel can also be customized with up to 100 genes.
+Added: The Xenium Analyzer instrument comes with onboard analysis capabilities to process image data, localize RNA signals and perform secondary analysis.
+Added: Customers are able to easily transfer data from the instrument and perform visualization and further analysis with 10x-provided software or other tools of their choice.
+Added: With the launch of our Xenium platform in 2022, we introduced Xenium Explorer, an easy-to-use desktop software tool for interactive exploration and data analysis.
+Added: Xenium Explorer leverages the platform's exploration-ready output to enable researchers to immediately see results at subcellular and tissue scale.
+Added: Our software is essential to our mission of accelerating the mastery of biology.
+Added: Since our platforms and molecular assays enable new levels of resolution and scale, they produce entirely new types of data and at much larger scales than previously achievable.
+Added: To that end, we have developed sophisticated and scalable software that completes our solutions which we provide to researchers generally free of charge.
+Added: Our analysis software transforms large amounts of raw data into usable results, giving researchers user friendly tools to dynamically explore these results.
+Added: As larger and larger amounts of biological data are generated with greater ease, we believe that software tools will become increasingly critical for progress in biology.
+Added: Our 10x Genomics Cloud Analysis platform makes it easy for new 10x users to get started and for our advanced users to scale to larger and more complex experiments.
+Added: With Cloud Analysis, we took the technology that powered our own internal product development for years and brought it to our customers.
+Added: Optimized for our software products, Cloud Analysis aims to be the easiest-to-use and fastest way to run 10x analysis available.
+Added: And because we believe analysis is an integral part of our products, we provide ample cloud analysis at no additional cost for every sample our customers run.
+Added: Since our founding, we have committed to making software engineering and computational biology world-class, core internal competencies.
+Added: We believe this deep investment distinguishes us from our competition and is worthwhile because it:
+Added: • Removes barriers to adoption.
+Added: With our software, our customers can immediately begin making sense of their experimental data.
+Added: Without it, they would be forced to develop their own software or wait for the community to do so, slowing down adoption of our products by months or even years;
+Added: • Accelerates utilization.
+Added: Easy-to-use, efficient software helps our customers analyze their data and complete their experiments and studies faster, enabling them to move on to their next experimental questions sooner;
+Added: • Increases scale.
+Added: Reliable, scalable software helps to remove analysis as a bottleneck as our customers plan larger and more ambitious experimental designs;
+Added: • Expands the user base.
+Added: While early adopters are more likely to have access to bioinformatics expertise, our software enables a broader range of customers to take advantage of our solutions;
+Added: • Enables better understanding of our customers’ needs.
+Added: By supplying analysis software for our customers, we gain much greater insight into their use cases, helping us to design future products that best meet their needs;
+Added: • Enhances and accelerates product development.
+Added: The software we ship to customers is the same software we use to develop and optimize our platforms and chemistry.
+Added: This aligns us closely with the needs of our customers and reduces our time-to-market.
+Added: Our product development approach
+Added: The success of our products is founded on how we approach product development.
+Added: Our employees are deeply scientifically oriented, having the relevant scientific expertise embedded not only within research and development, but also within the management team and throughout the company.
+Added: We are ambitious and focus on fundamentals.
+Added: We strive to solve big challenges to enable new fundamental biology and to build technological capabilities with potential for exponential impact.
+Added: We work closely with our customers, many of whom are thought leaders in genomics and medicine, to identify future frontiers and unmet needs.
+Added: Once we identify the correct opportunities, which we create through both organic development by our in-house teams and targeted acquisitions of technologies that will accelerate our ability to bring new products to researchers, we have the discipline to focus on execution and have a track record of bringing successful products across multiple platforms to market.
+Added: Multidisciplinary collaboration and technological innovation are central to our product development process.
+Added: We have built teams with deep expertise across diverse disciplines including chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering.
+Added: This multidisciplinary expertise forms the basis of our innovation engine, which allows us to introduce new products at a rapid pace as well as continuously launch improved versions of our existing products.
+Added: Our solutions enable our customers to focus on biology by providing them with intuitive user interfaces and software.
+Added: Our products guide customers through the workflow, from preparing samples, to reading sample information on a third-party sequencer (when required), through analyzing and visualizing this information, to make obtaining biological answers as easy as possible.
+Added: Our Chromium and Visium workflows operate with third-party sequencers that are widely available in research settings.
+Added: Our market opportunity
+Added: According to industry sources, the worldwide life sciences research tools market totaled more than $67 billion in 2021.
+Added: Our diverse products and solutions allow biologists to interrogate and understand biological systems at exceptional resolution and scale.
+Added: Our focus on enabling a comprehensive view of biology, and not narrowly focusing on a particular analyte such as DNA alone, has produced products which we believe have broad applications and target numerous opportunities across different areas of life sciences research.
+Added: Because we provide solutions to answer a broad diversity of biological questions, we view much of this total market as ultimately accessible to us.
+Added: Areas in which our current solutions offer alternative or complementary approaches to existing tools represented a total opportunity of approximately $16 billion of the more than $67 billion global life sciences research tools market in 2021.
+Added: This $16 billion opportunity includes flow cytometry, sequencing, microscopy, high content imaging and sample preparation, among other tools.
+Added: In many cases, our current solutions offer alternative approaches to existing tools, where the advantages of our solutions can provide more precise answers to existing biological questions than existing tools and technologies.
+Added: Our tools may also complement, enhance and enable new applications of these technologies.
+Added: We believe we will compete for research spending within the life science research tools market and capture an increasing share of research budgets as our solutions deliver new capabilities, enable new applications and lead to new discoveries.
+Added: We also expect to pursue additional opportunities that will further expand our opportunity, including new potential applications of our single cell, spatial and in situ technologies in the future.
+Added: We believe the opportunity can also be assessed through the application areas of our tools and the types of questions that researchers are looking to answer.
+Added: We estimate that there are four categories of research areas:
+Added: Cell Atlassing.
+Added: This refers to research that is looking to identify the cellular and molecular building blocks of tissues and work that allows for a baseline characterization of the cells in a system.
+Added: We estimate this opportunity is $2 billion;
+Added: Genetic Mechanisms.
+Added: This refers to research to determine the role of genetics in biological processes and understand genes and their function.
+Added: We estimate this opportunity is $2 billion;
+Added: Cellular and Molecular Biology.
+Added: This refers to research to understand the functions of specific gene, protein or cellular pathways.
+Added: We estimate this opportunity is $5 billion;
+Added: Translational.
+Added: This refers to research that applies biological learnings to improve human health.
+Added: Whether for clinical research, within research hospitals or within biopharmaceutical companies, translational research is typically completed by researchers who are looking to understand human tissues and to discover biomarkers or test and develop therapeutics with the goal of impacting human health and disease.
+Added: We estimate this opportunity is $7 billion.
+Added: Growth of our opportunity is also driven by a broad and increasing range of applications for our solutions.
+Added: Our solutions can be used in many different applications, including basic biology, oncology and immuno-oncology, genetic disease, neurological disease, autoimmunity, infectious disease, the human microbiome and many others.
+Added: In the “Century of Biology,” we believe that
+Added: the mastery of biology will create advances and benefits for a broad and growing range of industries including broader segments of the healthcare industry and beyond.
+Added: Our competitive strengths
+Added: We believe our continued growth will be driven by the following competitive strengths:
+Added: Our position as a leader in a large and growing market.
+Added: Since launching our first product in mid-2015 through December 31, 2022, cumulatively we have sold 4,630 instruments and we serve thousands of researchers globally.
+Added: We have fostered deep relationships with many key opinion leaders and as of December 31, 2022, our customers included all of the top 100 global research institutions as ranked by Nature in 2021 based on publications and all of the top 20 global biopharmaceutical companies by 2021 research and development spend.
+Added: Our products are an important part of our customers’ workflow and a significant portion of them utilize more than one of our solutions.
+Added: Our technologies have become a vital tool for biological research.
+Added: To date, more than 4,500 peer-reviewed articles have been published based on data generated using our products.
+Added: Our position as a leader in this market allows us to form deep partnerships with our customers who help us stay on the frontiers of biology, giving us insight on industry needs that inform our product strategy and providing us with a strong competitive advantage.
+Added: Our proprietary technologies.
+Added: Through multiple years of development, acquisition and in-licensing, we have amassed a core set of technologies and intellectual property rights that form the foundation of our growing suite of products and solutions.
+Added: These technologies, including instruments, assays and software, combine a diverse set of disciplines, including chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering.
+Added: Our technologies underlie features and performance that differentiate our products from the competition.
+Added: Further, many of these technological elements can be utilized across multiple products, enabling us to leverage our existing infrastructure and investment when building future products, increasing the speed of product development and product performance.
+Added: Worldwide we own or exclusively in-license over 700 issued or allowed patents and more than 1,050 pending patent applications as of December 31, 2022.
+Added: In addition to these owned and exclusively licensed patents and pending patent applications, we also license patents on a non-exclusive and/or territory restricted basis.
+Added: Our intellectual property portfolio includes important patents and patent applications directed to single cell analysis, epigenomics, spatial analysis, in situ analysis and multi-omics.
+Added: Our rigorous product development processes and scalable infrastructure.
+Added: We have implemented a rigorous and systematic product development process by which our vision can be efficiently translated into commercial products.
+Added: We develop our products over a set of defined phases delineated by validating multifunctional reviews, which ensure our teams remain focused on quality, efficiency and profitability.
+Added: This process allows many highly focused teams to execute on separate product development efforts in parallel while drawing effectively on the resources and capabilities of the company.
+Added: We have also built extensive technological and operational infrastructure to support the efficient execution of these teams.
+Added: This infrastructure includes multiple technological investments across a range of areas, including custom barcoded gel bead production, microfluidic chip manufacturing, scalable high-performance computation and automated software productization and testing tools.
+Added: This infrastructure can be drawn on to develop new products and improved versions of our existing products with high quality at a rapid pace.
+Added: Our customer experience and broad commercial reach.
+Added: We believe in providing our customers with a high-quality experience from start to finish:
+Added: starting with a collection of validated methods for preparation of samples to be run on our systems and ending with extensive software to aid in analysis and visualization of the data generated.
+Added: We have also built comprehensive product testing and quality control into our culture and processes to help guarantee the performance of our products in customer hands.
+Added: As of December 31, 2022, we employed a commercial team of 453 full time employees.
+Added: This includes an extensive and highly specialized customer service infrastructure with technical specialists covering multiple areas of expertise, including experimental biology, tissue analysis and handling and software.
+Added: Many members of our sales and customer service teams have a PhD degree and have significant industry experience.
+Added: Both our sales and customer service teams help ensure our customers are successful in designing and executing their experiments and have a positive experience with our products.
+Added: Our experienced multidisciplinary team .
+Added: At 10x, we have built a multidisciplinary team with talent and expertise across a diverse set of areas such as chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering who are committed to identifying and addressing problems at the forefront of biology.
+Added: We have supplemented our diverse technical experience by assembling an operational team with expertise in manufacturing, legal, sales, marketing, customer service, human resources and finance.
+Added: We believe this confluence of talent from multiple disciplines at 10x allows us to stay ahead of our competitors by identifying highly impactful opportunities and building products and solutions that address these opportunities.
+Added: Our growth strategy
+Added: Our growth strategy includes the following key elements:
+Added: Develop critical enabling technologies .
+Added: Just as our past success is attributable to our innovative technologies, we believe that our future growth will be driven in large part by our significant continued investment in research and development.
+Added: We aim to build platforms, consumables and software that further our goals of interrogating, understanding and mastering biological systems at the needed resolution and scale and drive adoption by delivering better insights, workflows and cost structure.
+Added: We prioritize innovations that meet large unmet market needs, such as measuring novel biological analytes with key functional impact at the single cell level or with spatial context.
+Added: We design our products to facilitate the expansion of single cell approaches into more areas of academic research, to increase adoption of single cell approaches in translational and biopharmaceutical applications and to harness the emergence of spatial biology as a bridge between genomics and pathology.
+Added: We expect that our investments in research and development will allow us to increase our penetration of our accessible markets.
+Added: Expand sales of our instruments .
+Added: Since our commercial launch in mid-2015 through December 31, 2022, cumulatively we have sold 4,630 instruments and serve thousands of researchers globally.
+Added: We will target new customers in addition to expanding the number of 10x instruments within institutions that have already recognized the significant value of our technology.
+Added: A portion of our current laboratory customers do not yet own a 10x instrument, but rather gain access to one of our instruments through an adjacent lab or core facility within the institution.
+Added: These customers are substantial and easily accessible and therefore represent an opportunity for future instrument sales.
+Added: We also intend to expand our existing geographic reach, both directly and through distributors.
+Added: Strengthen use and adoption of our consumables .
+Added: Our instruments are designed to be used exclusively with our consumables.
+Added: This closed system generates recurring revenue from consumables tied to each instrument we sell.
+Added: We plan to drive wider adoption of our products within the workflows of our existing customers.
+Added: For example, although many biopharmaceutical companies use our products in early drug discovery phases from target identification to validation and across multiple sites, we believe that as our applications are increasingly incorporated into later stages in the drug development process, the amount of our consumables used will grow.
+Added: We have a dedicated global strategic sales, marketing and business development team to support the adoption cycle by biopharmaceutical companies.
+Added: We have also added new instruments to our instrument lineup which are aimed at addressing new customer use cases and driving higher consumable revenue growth including our Chromium Connect instrument in 2020, Chromium X Series in 2021 and Visium CytAssist instrument and Xenium Analyzer in 2022.
+Added: We also plan to demonstrate new applications using our solutions, including applications that synergistically use multiple 10x solutions, to investigate the potential clinical utility of single cell and spatial approaches enabled by our solutions.
+Added: Identify the most relevant technologies, create or acquire such technologies and develop them into new products .
+Added: Over the years, we have developed, acquired or in-licensed a core set of technologies and associated intellectual property rights across a broad range of emerging areas within biology and life sciences.
+Added: The ability to identify these core technologies and capabilities has complemented our internal product development process and enhanced our growing suite of products and solutions.
+Added: We will continue to identify and acquire or in-license technologies and intellectual property rights that accelerate the development of new features and products or complement our existing features, products and technologies.
+Added: For instance, we acquired Epinomics, Inc.
+Added: (“Epinomics”) and Spatial Transcriptomics Holdings AB (“Spatial Transcriptomics”) in 2018, obtaining technology and intellectual property that formed the foundation of our ATAC-seq assay and Visium platform, respectively.
+Added: We acquired ReadCoor, Inc.
+Added: ("ReadCoor") and CartaNA AB ("CartaNA") in 2020, obtaining intellectual property, key technology advances and deep talent and expertise in the emerging in situ field and when combined with internal innovations formed the foundation for our Xenium platform.
+Added: Additionally, in January 2021 we acquired Tetramer Shop ApS, a developer and provider of reagents for precise monitoring of antigen-specific T cells in research and development, enabling us to strengthen our efforts in immunology.
+Added: We commercialized this technology with our BEAM-T product in 2022.
Peer-reviewed scientific publications using our products
2 unchanged sentences
Cell , Nature and Science .
−Removed: Underscoring the reach of our products, these publications cover a wide range of research and applied areas from cell biology to genetic health to neuroscience with the top three areas of publication, according to our estimates, being immunology, developmental biology and cancer research.
−Removed: Research area
−Removed: Number of articles
−Removed: Immunology 573 17.3 %
−Removed: Cancer Research 518 15.6
−Removed: Developmental Biology 494 14.9
−Removed: Computational Method 306 9.2
−Removed: Neuroscience 299 9.0
−Removed: Cell Atlas 173 5.2
−Removed: Infectious Disease 137 4.1
−Removed: Cell Biology 135 4.1
−Removed: Genome Assembly 135 4.1
−Removed: Assay Method 111 3.3
−Removed: Genetic Health 87 2.6
−Removed: Immuno-Oncology 75 2.3
−Removed: Agrigenomics 61 1.8
−Removed: Genome Analysis 53 1.6
−Removed: Reproductive Biology 37 1.1
−Removed: Functional Genomics 31 0.9
−Removed: Method Comparison 29 0.9
−Removed: Conservation Biology 18 0.5
−Removed: Cardiovascular 16 0.5
−Removed: Population Genetics 16 0.5
−Removed: Microbiology 9 0.3
−Removed: Single Cell Multiomics Method 5 0.2 %
−Removed: We have seen robust quarter-over-quarter growth in the number of publications commensurate with our commercial growth and success:
−Removed: These publications describe, for example, the use of our products to:
−Removed: • Integrate single-cell transcriptomics, antibody sequencing and antibody binding to profile the molecular features of the antibody response to influenza vaccination;
−Removed: • Identify the immune cell signature of bacterial sepsis;
−Removed: • Investigate the pathology of SARS-CoV-2, identify potent neutralizing antibodies, and develop potential treatments;
−Removed: • Map the spatial architecture and cellular composition of cutaneous squamous cell carcinoma in human skin;
−Removed: • Overturn a previous mechanistic theory for immune checkpoint blockade by showing peripheral recruitment of novel CD8 + T-cell clones in multiple types of cancer;
−Removed: • Define cellular and genetic networks linked to amyloid plaque formation in Alzheimer’s disease;
−Removed: • Characterize the window of implantation during the human menstrual cycle by creating transcriptomic profiles of endometrial cell types.
+Added: Underscoring the reach of our products, these publications cover a wide range of research and applied areas from cell biology to genetic health to neuroscience with the top three areas of publication, according to our estimates, being oncology, immunology and developmental biology.
+Added: Recent publications describe, for example, the use of our products to:
+Added: • Understand the heterogeneity driving treatment resistance in pancreatic ductal adenocarcinoma;
+Added: • Characterize early kinetics in tumor-infiltrating and circulating immune cells in oral cancer patients treated with immune checkpoint blockade therapy in a clinical trial;
+Added: • Investigate why human ovarian cancer is poorly responsive to immunotherapy;
+Added: • Create a cell atlas of the adult human cerebrovasculature by profiling single cell transcriptomes of brain cells to reveal the geographical organization of molecularly defined cerebrovascular cell types in the human brain by using spatial transcriptomics.
Research and development
Our research and development teams have designed and developed our proprietary products using an interdisciplinary approach that combines expertise across the fields of chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering.
−Removed: Our research and development groups work together in cross-functional project teams;
−Removed: an approach that has been key to our success to date.
−Removed: Our research and development teams are currently located in our headquarters in Pleasanton, California, in Stockholm, Sweden, in Copenhagen, Denmark and in Singapore.
+Added: Our research and development groups work together in cross-functional project teams, an approach that has been key to our success to date.
+Added: Our research and development teams are currently located in our headquarters in Pleasanton, California, in Stockholm, Sweden and in Singapore.
The overarching goals of our research and development programs are to continue to bring new technologies to market that address the most pressing questions in biology and to provide exponential advances in human health.
4 unchanged sentences
Develop new solutions for our Chromium platform .
−Removed: We plan to expand the range of solutions that are available on our Chromium platform to allow researchers access to new types of biological information.
−Removed: For example, we are planning to develop additional multi-omics solutions on our Chromium platform for simultaneous interrogation of different classes of analytes.
+Added: We plan to expand the range of solutions that are available on our Chromium platform to allow researchers access to new types of starting sample types and biological information.
+Added: For example, in 2022, we launched our Single Cell Gene Expression Flex Kit which allows researchers to measure gene activity on a cell-by-cell basis from samples that are fresh, fixed with paraformaldehyde (PFA) or formalin-fixed paraffin-embedded (FFPE) and our Nuclei Isolation kit which provides a simple, scalable workflow to make frozen tissues and previously challenging sample types more accessible for routine single cell analysis.
Develop new solutions for our Visium platform .
In 2019, we introduced the first product on our Visium platform, which offers high spatial resolution, high sensitivity, efficient workflow and analysis and visualization software.
+Added: We launched the Visium Spatial Proteogenomics solution providing the capability of combining whole transcriptome analysis and immunofluorescence protein detection within the same tissue section in 2020.
In 2021, we launched Visium Spatial Gene Expression for FFPE enabling Visium to be applied to FFPE tissues with similarly high sensitivity and the same spatial resolution as fresh frozen samples.
+Added: In 2022, we launched the Visium CytAssist, an instrument designed to simplify the Visium solution workflow by facilitating the transfer of transcriptomic probes from standard glass slides to Visium slides.
+Added: Along with the launch of the instrument, we also launched the Visium Spatial Gene Expression for FFPE on CytAssist, enabling our Visium for FFPE product to be used with the CytAssist instrument.
We are working to develop new technologies for our Visium platform that will further enhance the spatial resolution, usability and automation of our platform.
−Removed: Improve and develop new capabilities for our Chromium instruments .
−Removed: We plan to develop new capabilities that would improve the usability and increase the performance of our Chromium instruments by increasing automation, throughput, workflow visibility or troubleshooting capabilities.
+Added: Develop new solutions for our Xenium platform .
+Added: In 2022, we launched our Xenium Human Breast Gene Expression Panel for high-resolution cell typing of breast tissues and characterization of breast cancer disease states, including tumor microenvironments, and our Xenium Mouse Brain Gene Expression Panel enabling high-resolution cell typing of mouse brain tissue.
+Added: Improve and develop new capabilities for our instruments .
+Added: We plan to develop new capabilities that would improve the usability and increase the performance of our instruments by increasing automation, throughput, workflow visibility or troubleshooting capabilities.
Develop combined software and workflows across multiple solutions.
+Added: Our platforms are highly synergistic and leverage shared technologies, workflows and software.
We plan to develop workflows that enable users to run multiple assays on the same biological samples and software that simultaneously analyzes the data generated from these multiple assays.
We plan to do this for key solution combinations where the information obtained from the two solutions is highly complementary.
−Removed: Investigate and develop new technologies, including our emerging Xenium platform .
+Added: Investigate and develop new technologies .
We will seek to both develop and acquire new technologies that could be additive to or complementary with our current portfolio.
−Removed: For example, in 2020, we acquired ReadCoor and CartaNA, which when combined with internal innovations form the basis of our forthcoming Xenium In Situ Analysis Platform.
+Added: For example, in 2020, we acquired ReadCoor and CartaNA, which when combined with internal innovations formed the basis of our Xenium platform.
Our research and development costs were $265.7 million and $211.8 million for the years ended December 31, 2022 and 2021, respectively.
−Removed: In-process research and development costs, consisting of costs incurred to acquire intellectual property for research and development were $447.5 million for the year ended December 31, 2020.
−Removed: There were no similar acquisitions in the year ended December 31, 2021.
As of December 31, 2022, we employed 448 employees in research and development.
−Removed: Looking forward, we
−Removed: will continue to invest in efforts to support the ongoing development of our instruments, consumables and software across all three of our platforms, as well as enhance the overall performance of our solutions.
+Added: Looking forward, we will continue to invest in efforts to support the ongoing development of our instruments, consumables and software across all three of our platforms, as well as enhance the overall performance of our solutions.
Commercial team
−Removed: We began the full launch of our first product in mid-2015 and have since sold thousands of products globally.
+Added: Since launching our first product in mid-2015, we have expanded our commercial operations and now sell our products in 50 countries.
Our customers primarily include academic, government, biopharmaceutical, biotechnology and other institutions focused on life sciences research.
We sell our products primarily through our own direct sales force in North America and certain regions of Europe.
−Removed: As of December 31, 2021, our commercial organization consisted of 417 full time employees, including more than 160 commissioned sales representatives, many with PhD degrees and many with significant industry experience.
+Added: As of December 31, 2022, our commercial organization consisted of 453 full time employees, many with PhD degrees and many with significant industry experience.
We sell our products through third-party distributors in Asia, certain regions of Europe, Oceania, South America, the Middle East and Africa.
−Removed: We have sold products in more than 45 countries.
For both the years ended December 31, 2022 and 2021, no single customer, including distributors, represented greater than 10% of our business.
3 unchanged sentences
Our products are integrated solutions comprised of instruments, consumables and software.
−Removed: We aim to drive customer adoption and sales of our Chromium instruments which then forms a base of users who drive revenue by purchasing our consumables.
+Added: We aim to drive customer adoption and sales of our instruments which then forms a base of users who drive revenue by purchasing our consumables.
Our products are designed to be easy to install and use without the need for extensive training.
1 unchanged sentence
Our strategy typically involves targeting key opinion leaders during the initial phase of our product launches, after which we aim to expand adoption of our products across a broader base of customers.
−Removed: As our customer base has grown, we have been able to sell more instruments to accelerate the adoption of new solutions.
−Removed: Over half of our customers purchased our consumables relating to more than one of our solutions in both the years ended December 31, 2021.
+Added: As our customer base has grown, we have been able to sell more
+Added: instruments to accelerate the adoption of new solutions.
+Added: Over half of our customers purchased our consumables relating to more than one of our solutions in both the years ended December 31, 2022 and 2021.
Our commercial strategy focuses on ensuring our customers are successful with our products.
1 unchanged sentence
Since our first product launch in 2015, there have been more than 4,500 publications by researchers using data generated by our products.
−Removed: Our direct sales and marketing efforts are targeted at the principal investigators, research scientists, department heads, research laboratory directors and core facility directors at leading academic institutions, biopharmaceutical companies and publicly and privately funded research institutions who control the buying decision.
+Added: Our sales and marketing efforts are targeted at the principal investigators, research scientists, department heads, research laboratory directors and core facility directors at leading academic institutions, biopharmaceutical companies and publicly and privately funded research institutions who control buying decisions.
Due to the pricing of our instruments and consumables, the buying decision is typically made by the principal investigator rather than by committee or department chair, which we believe simplifies the purchasing decision and has helped accelerate adoption of our products.
−Removed: We also target researchers who do not own their own Chromium Controller instrument, but who have access to one, which we refer to as “halo users.” By sharing one instrument across groups within an institution, multiple halo users are able to utilize the instrument for their own research and experiments, contributing meaningfully to consumable pull-through on just one instrument.
−Removed: Halo users help drive consumable revenue and utilization of our consumable products and may become future purchasers of a Chromium instrument.
−Removed: The use of our products requires the access to, but not necessarily the ownership of, a third-party next-generation sequencer.
−Removed: Since sequencers are often accessible as a shared resource, our target customer base is broader than those who own a next-generation sequencer.
+Added: We also target researchers who do not own their own 10x instrument, but who have access to one, which we refer to as “halo users.” By sharing one instrument across groups within an institution, multiple halo users are able to utilize the instrument for their own research and experiments.
+Added: Halo users help drive consumable revenue and utilization of our consumable products and may become future purchasers of a 10x instrument.
+Added: The use of our Chromium and Visium products requires the access to, but not necessarily the ownership of, a third-party sequencer.
+Added: Since third-party sequencers are often accessible as a shared resource and because our Xenium platform does not require the use of a third-party sequencer, our target customer base is broader than those who own a third-party sequencer.
We increase awareness of our products among our target customers through direct sales calls, trade shows, seminars, academic conferences, web presence, social media and other forms of internet marketing.
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We believe that having dual sources for our components helps reduce the risk of a production delay caused by a disruption in the supply of a critical component.
−Removed: For further discussion of the risks relating to our third-party suppliers, see the section titled “ Risk Factors—Risks related to our business and industry—We and our customers are dependent on single source and sole source suppliers for some of the equipment, components and materials used in our products and the loss of any of these suppliers could harm our business .
−Removed: The ability of our suppliers to meet our needs and the needs of our customers could be reduced or eliminated by the impacts of the COVID-19 pandemic.
−Removed: We outsource manufacturing for our Chromium Controller, Chromium X Series and Chromium Connect to a qualified contract manufacturer.
−Removed: This manufacturer has represented to us that they maintain ISO 13485 certification.
+Added: For further discussion of the risks relating to our third-party suppliers, see the section titled “ Risk Factors—Risks related to our business and industry—We and our customers are dependent on single source and sole source suppliers for some of the equipment, components and materials used in our products and in conjunction with our products and the loss of any of these suppliers could harm our business.
+Added: We outsource manufacturing for our Chromium and Visium CytAssist instruments to qualified contract manufacturers who have represented to us that they maintain ISO 13485 certification.
Our Chromium Connect includes an automated workflow liquid handling robot which is manufactured by our partner.
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We have built a multidisciplinary team with talent and expertise across a diverse set of areas such as chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering, and have supplemented this diverse technical experience with our operational team with expertise in manufacturing, legal, sales, marketing, customer service, human resources and finance.
−Removed: As of December 31, 2021, we employed a total of 1,239 individuals, 956 of whom were employed in the United States and 283 of whom were employed outside the United States.
−Removed: As of December 31, 2021, our 1,239 employees included 464 in research and development, 417 in sales, marketing and support, 230 in general and administrative and 128 in manufacturing, of which many hold PhDs in their respective disciplines.
−Removed: Additionally, most of our senior management team and the members of our board of directors hold either PhDs and/or other advanced degrees.
+Added: December 31, 2022, we employed a total of 1,243 individuals, 931 of whom were employed in the United States and 312 of whom were employed outside the United States.
+Added: As of December 31, 2022, our employees included 448 in research and development, 453 in sales, marketing and support, 213 in general and administrative and 129 in manufacturing, many of whom hold PhDs in their respective disciplines.
+Added: Additionally, most of our senior management team and the members of our board of directors hold PhDs and/or other advanced degrees.
Our Company's scientific expertise is therefore embedded within the management team and throughout the organization.
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Our employees are highly motivated by our mission.
−Removed: We embrace diversity and inclusion.
−Removed: We value diversity at all levels and continue to focus on extending our diversity and inclusion initiatives across our entire workforce.
−Removed: We believe that our business benefits from the different perspectives a diverse workforce brings, and we pride ourselves on having a strong, inclusive and positive culture based on our shared mission and values.
We continue to emphasize employee development and training.
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The life sciences market is highly competitive.
−Removed: There are other companies, both established and early stage, that have indicated that they are designing, manufacturing and marketing products for, among other things, genomics analysis, single cell analysis, spatial analysis and in situ analysis.
−Removed: These companies include Becton, Dickinson and Company and Nanostring Technologies, Inc., each of which has products that compete with our products, as well as a number of other emerging and established companies.
−Removed: Some of these companies may have substantially greater financial and other resources than us, including larger research and development staff or more established marketing and sales forces.
+Added: Companies, both established and early stage, have introduced products for, among other things, genomics analysis, single cell analysis, spatial analysis and in situ analysis.
+Added: Additional companies, including both early stage and established, have indicated that they are designing, manufacturing and marketing products to compete with us or that they intend to do so in the future.
+Added: Some of these companies may have substantially greater financial and other resources than we do, including larger research and development staff or larger, more established marketing, distribution, service and sales organizations.
+Added: In addition, they may have greater name recognition than we do.
Other competitors are in the process of developing novel technologies for the life sciences market which may lead to products that rival or replace our products.
−Removed: We believe we are differentiated from our competitors for many reasons, including our position as a leader in a large and growing market, proprietary technologies, rigorous product development processes and scalable infrastructure, customer experience and multidisciplinary teams.
+Added: We expect new competitors to emerge and the intensity of competition to increase.
+Added: We believe we are differentiated from our competitors for many reasons, including our position as a leader in a large and growing market, advanced proprietary technologies protected by substantial intellectual property, rigorous product development processes and scalable infrastructure, superior customer experience and multidisciplinary teams.
We believe our customers favor our products and company because of these differentiators.
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Pursuant to its authority under the FDC Act, the FDA has jurisdiction over medical devices, which are defined to include, among other things, in vitro diagnostic devices (“IVDs”).
−Removed: In the EU, Directive 98/79/EC (“EU IVDD”) currently governs the rules applicable to IVDs.
−Removed: The EU IVDD defines an IVD as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
−Removed: (i) concerning a physiological or pathological state, or (ii) concerning a congenital abnormality, or (iii) to determine the safety and compatibility with potential recipients, or (iv) to monitor therapeutic measures.” National competent authorities of the EU member states enforce compliance with medical devices (including IVDs) requirements.
+Added: In the EU, until May 25, 2022, IVDs were regulated by Directive 98/79/EC (“EU IVDD”), which has been repealed and replaced by Regulation (EU) No 2017/746 (“EU IVDR”).
+Added: The EU IVDR establishes a modernized and more robust EU legislative framework, with the aim of ensuring better protection of public health and patient safety.
+Added: Unlike the EU IVDD, the EU IVDR is directly
+Added: applicable in all EU member states without the need for member states to implement into national law.
+Added: This aims at reducing the risk of discrepancies in interpretation across the different European markets.
+Added: The EU IVDR became applicable on May 26, 2022.
+Added: The EU IVDR defines an IVD as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
+Added: (a) concerning a physiological or pathological process or state;
+Added: (b) concerning congenital physical or mental impairments;
+Added: (c) concerning the predisposition to a medical condition or a disease;
+Added: (d) to determine the safety and compatibility with potential recipients;
+Added: (e) to predict treatment response or reactions;
+Added: (f) to define or monitor therapeutic measures.” National competent authorities of the EU member states enforce compliance with medical devices (including IVDs) requirements.
The EU rules are generally applicable in the European Economic Area (“EEA”) (which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland).
−Removed: We believe that our current products are not medical devices within the meaning of the FDC Act and foreign regulations applicable in countries where we market our products, such as the EU IVDD in the EU, but we nevertheless market our products for research use only (“RUO”).
+Added: We believe that our current products are not medical devices within the meaning of the FDC Act and foreign regulations applicable in countries where we market our products, such as the EU IVDR in the EU, but we nevertheless market our products for research use only (“RUO”).
IVDs that are marketed for RUO are not intended for use in a clinical investigation or for clinical diagnostic use outside an investigation and must be labeled “For Research Use Only.
Not for use in diagnostic procedures.” Products that are intended for RUO and are properly labeled as RUO are exempt from compliance with the FDA’s requirements applicable to medical devices more generally, including the requirements for clearance or approval and compliance with manufacturing requirements known as the Quality System Regulation.
−Removed: In the EU, the EU IVDD clearly indicates that:
−Removed: “instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation.” To be categorized as an RUO product, the product must have no intended medical purpose or objective.
−Removed: Consequently, products labeled as RUO are essentially not subject to compliance with the EU IVDD requirements such as conformity with the essential requirements laid down in the EU IVDD.
+Added: In the EU, the EU IVDR clearly indicates that it does not apply to “products or general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination," and that “a device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study.” To be categorized as an RUO product, the product must have no intended medical purpose or objective.
+Added: Consequently, products labeled as RUO are essentially not subject to compliance with the EU IVDR requirements such as conformity with general and safety requirements laid down in the EU IVDR.
+Added: Depending on the products in question, other regulations may be applicable to the RUO products.
A product labeled RUO but intended to be used diagnostically may be viewed by the FDA or foreign authorities as adulterated and misbranded under the FDC Act or foreign regulations and subject to FDA or foreign authorities enforcement action.
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In the EU, there is currently no premarket government review of medical devices (including IVDs).
−Removed: However, all IVDs placed on the EU market must meet the essential requirements of the EU IVDD including the requirement that an IVD must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.
−Removed: Compliance with the essential requirements of the IVDD is a prerequisite for European conformity marking (“CE mark”) without which IVDs cannot be marketed or sold in the EU.
+Added: However, all IVDs placed on the EU market must meet general and safety requirements of the EU IVDR including the requirement that an IVD must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose.
+Added: IVDs must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and– where applicable–other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.
+Added: Compliance with general and safety requirements of the EU IVDR is a prerequisite for European conformity marking (“CE mark”) without which IVDs cannot be marketed or sold in the EU.
The 510(k) clearance, PMA and CE mark processes can be resource intensive, expensive and lengthy, and require payment of significant (user) fees.
Medical devices are also subject to post-market requirements.
−Removed: Failure to comply with applicable regulations can result in enforcement actions such as:
−Removed: warning letters, fines, injunctions, civil or criminal penalties, termination of distribution, recalls or seizures of products, delays in the introduction of products into the market, total or partial suspension of production, refusal to grant future clearances, approvals or certifications, or withdrawals or suspensions of existing clearances, approvals or certifications.
−Removed: Rules governing medical devices including IVDs may change.
−Removed: For instance, the EU regulatory landscape concerning IVDs is evolving.
−Removed: On April 5, 2017 Regulation (EU) 2017/746 (“EU IVDR”) was adopted to establish a modernized and more robust EU legislative framework, with the aim of ensuring better protection of public health and patient safety.
−Removed: Unlike the EU IVDD, the EU IVDR is directly applicable in all EU member states without the need for member states to implement into national law.
−Removed: This aims at reducing the risk of discrepancies in interpretation across the different European markets.
−Removed: The EU IVDR will fully apply on May 26, 2022 but there will be a tiered system extending the grace period for many devices (depending on their risk classification) before they have to be fully compliant with the regulation.
−Removed: The EU IVDR expressly provides that products intended for RUO are excluded from the scope of the regulation.
−Removed: A material intended for RUO, without any medical purpose or objective, is therefore not considered as an IVD and is not subject to compliance with the IVD requirements.
−Removed: Depending on the products in question, other regulations may be applicable to the RUO products.
+Added: Failure to comply with applicable regulations can result in enforcement actions such as warning letters, fines, injunctions, civil or criminal penalties, termination of distribution, recalls or seizures of products, delays in the introduction of products into the market, total or partial suspension of production, refusal to grant future clearances, approvals or certifications or withdrawals or suspensions of existing clearances, approvals or certifications.
Intellectual property
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We utilize a variety of intellectual property protection strategies, including patents, trademarks, trade secrets, copyright and other methods of protecting proprietary information.
−Removed: Worldwide we own or exclusively in-license over 460 issued or allowed patents and 830 pending patent applications as of December 31, 2021.
+Added: Worldwide we own or exclusively in-license over 700 issued or allowed patents and more than 1,050 pending patent applications as of December 31, 2022.
We also license additional patents on a non-exclusive and/or territory restricted basis.
22 unchanged sentences
We cannot provide any assurance that any of our current or future patent applications will result in the issuance of patents, or that any of our current or future issued patents will effectively protect any of our products or technology from infringement or prevent others from developing, manufacturing or commercializing products or technology that infringe, breach or violate our intellectual property rights.
−Removed: For further discussion of the risks relating to intellectual property, see the section titled “ Risk Factors—Risks related to litigation and our intellectual property .”
+Added: For further discussion of the risks relating to intellectual property, see the sections titled “ Risk Factors—Risks related to our intellectual property, information technology and data security ” and “ Risk Factors—Risks related to litigation and our intellectual property .”
Data Privacy and Security
1 unchanged sentence
In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information.
−Removed: In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.
−Removed: For example, the European Union General Data Protection Regulation (“GDPR”) imposes strict requirements for processing the personal data of individuals within the European Economic Area (“EEA”).
−Removed: Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater.
−Removed: Further, from January 1, 2021, companies have had to comply with the GDPR and also the United Kingdom GDPR (“UK GDPR”), which, together with the amended United Kingdom Data Protection Act 2018, retains the GDPR in United Kingdom national law.
−Removed: The UK GDPR mirrors the fines under the GDPR, i.e., fines up to the greater of €20 million (£17.5 million) or 4% of global turnover.
+Added: In addition, certain foreign laws govern the privacy and security
+Added: of personal data, including health-related data.
Privacy and security laws, regulations and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.
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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.