Our mission is to accelerate the mastery of biology to advance human health.
−Removed: We are a life science technology company focused on building innovative products to interrogate, understand and master biology.
−Removed: Our integrated platform 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 sciences technology company focused on building innovative products and solutions to interrogate, understand and master biology.
+Added: Our integrated 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.” 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: 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, we and our two long read sequencing company partners launched products and protocols providing the ability to obtain full-length isoforms at single cell resolution.
This groundbreaking capability was highlighted as part of the Nature Methods 2022 “Method of the Year” Long-read sequencing.
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.
−Removed: 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.
+Added: Since launching our first product in mid-2015 through December 31, 2023, we have sold 5,966 instruments to researchers around the world, including academic and translational researchers and biopharmaceutical companies.
We believe that we remain in the very early stages of our penetration into multiple large markets.
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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 resolution and on massive scale, which are inaccessible with previously 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 resolutions 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.
Our product portfolio consists of multiple integrated platforms that include instruments, consumables and software.
−Removed: These platforms guide customers through the workflow from sample preparation to analysis and visualization.
+Added: These integrated solutions guide customers through the workflow from sample preparation to analysis and visualization.
Each of our platforms is designed to interrogate a major class of biological information that is impactful to researchers at high resolution and scale:
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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 Chromium platform offers comprehensive solutions to measure tissues at single cell resolution and scale.
+Added: Chromium enables multiomic readouts including gene expression, protein, chromatin, V(D)J, CRISPR/guide RNAs (gRNAs) and antigens, has broad sample compatibility (formalin-fixed paraffin-embedded (FFPE), fresh, frozen and paraformaldehyde (PFA) fixed tissue and whole blood) and delivers high performance including high cell recovery rates (CRE), high sensitivity, robustness and reproducibility.
• 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.
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• 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.
−Removed: 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: Xenium In Situ detects and preserves the cellular localization of hundreds of RNA targets directly in a fresh frozen or 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.
Collectively, our platforms enable researchers to interrogate, understand and master biology at the appropriate resolution and scale.
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We prioritize creating a superior user experience from pre-sales to onboarding through the generation of novel publishable discoveries, which drive awareness and adoption of our products.
−Removed: We have a scalable, multi-channel commercial infrastructure including a direct sales force in North America and certain regions of Europe and distribution partners in Asia, certain regions of Europe, Oceania, South America, the Middle East and Africa that drives our customer growth.
+Added: We have a scalable, multi-channel commercial infrastructure including a direct sales force in North America and certain regions of Europe and distribution partners in Asia, certain regions of Europe, Oceania, Central America, South America, the Middle East and Africa that drives our customer growth.
This is supplemented with an extensive and highly specialized customer service infrastructure with PhD-level specialists.
−Removed: We currently have customers in 50 countries.
+Added: We currently have customers in over 50 countries.
Our revenue was $618.7 million and $516.4 million for the years ended 2023 and 2022, respectively, representing a year-over-year growth rate of 20%.
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Information from the mRNA molecules is then translated into protein in a process called translation.
−Removed: 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,
−Removed: transcriptome or gene expression profile, and the proteome, respectively.
+Added: Each gene has the ability to create multiple different mRNAs, resulting in the production of over 100,000 different
+Added: mRNAs from about 30,000 genes.
+Added: The complete collection of all of the DNA, mRNA and proteins are called the genome, 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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• Limited number of biological analytes are interrogated, giving a myopic view of only a few biological processes;
−Removed: • Limited ability for multi-omic interrogation;
+Added: • Limited ability for multiomic interrogation;
• Inefficient use of sample to generate a signal of sufficient strength to analyze the biological molecules of interest;
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Our Visium platform allows researchers to combine spatially resolved whole transcriptome measurements across tissue sections with a high-resolution image.
−Removed: 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: Up to millions 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.
Our Xenium platform includes the Xenium Analyzer, a fully automated instrument that integrates sample handling, liquid handling and imaging.
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Our Chromium consumables run on our Chromium instruments.
−Removed: Our Chromium iX instrument is capable of running our Low Throughput and Standard Throughput consumables.
−Removed: Our Chromium X instrument is capable of running Low, Standard and High Throughput consumables.
−Removed: Customers are able to upgrade their Chromium iX to run Low, Standard and High Throughput consumables via firmware upgrade.
+Added: Our Chromium iX instrument is capable of running our Standard Throughput consumables.
+Added: Our Chromium X instrument is capable of running our Standard and High Throughput consumables.
+Added: Customers are able to purchase a license that upgrades their Chromium iX to a Chromium X, unlocking the ability to run our High Throughput consumables.
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.
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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 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: 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, Single Cell Gene Expression Flex and Single Cell Immune Profiling solutions.
The following are key advantages of our Chromium platform:
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Our single cell solutions have doublet rates of less than 1% per 1,000 cells.
+Added: • Different biochemistries to enable single cell research :
+Added: The Chromium platform offers two technical approaches—he probe-based approach (Chromium Flex) and the Reverse Transcription (RT)-based approach (Chromium 3’ and 5’) to measure gene and protein expression.
+Added: Both approaches cater to unique use cases, open the door for different applications and expand sample compatibility
Our Chromium platform currently provides researchers with the following solutions:
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Researchers can explore their data by cluster or gene(s) of interest to derive biological meaning from the visualizations.
−Removed: The following visualization is an example showing single cell profiling of approximately 10,000 mouse brain cells that reveals multiple types of neurons.
+Added: The following visualization is an example showing single cell profiling of approximately 26,000 human endometrium cells highlighting several subpopulations.
______________
−Removed: t-SNE projection of approximately 10,000 mouse brain cells derived from the combined cortex, hippocampus and ventricular zones of embryonic day 18 brain tissue.
−Removed: Major subpopulations were identified based on gene markers that are enriched in each class.
+Added: UMAP projection of approximately 26,000 human endometrium cells.
+Added: Major subpopulations were identified based on gene markers.
Our Chromium Single Cell Gene Expression solution uses our proprietary biochemistry, GEM-RT, to capture mRNA molecules with high sensitivity.
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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 our GEM-RT biochemistry that has an increased sensitivity of up to 8,500 unique transcripts per cell.
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.
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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: 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.
−Removed: This body of work is yielding significant insights into many different areas of biology and disease.
−Removed: For example, after the COVID-19 pandemic emerged in 2020, a coalition of researchers from the Human Cell Atlas Biological Network re-analyzed single cell gene expression datasets obtained from the respiratory system, retina, intestine, heart, muscle, liver, brain, skin and many other tissues and organs.
−Removed: 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 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.
−Removed: 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.
Single Cell Gene Expression Flex
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This advanced chemistry also brings single cell profiling to FFPE tissue, expanding the range of accessible sample types.
−Removed: 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.
−Removed: 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: A key advantage is that customers can fix whole fresh tissue pieces at the point of collection to lock in biological states and preserve fragile cells or use this solution to access archived samples, making it especially suited for translational and clinical labs where fragile samples or time constraints would otherwise preclude single cell analysis.
+Added: In addition, its probe-based approach requires only a small region of the transcript (50 base pairs in length) to be present in the cell in order for it to be detected, making it compatible with comparably low quality samples such as biopsies or other clinical samples that are prone to have increased levels of fragmented transcripts compared to other sample types.
+Added: Furthermore, our Chromium Single Cell Gene Expression Flex solution can be used with our Feature Barcode technology to simultaneously measure cell surface proteins and gene expression in the same cells.
Chromium Single Cell Gene Expression Flex allows for profiling up to 1,000,000 fixed single cells at once with a scalable workflow.
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Sequencing libraries are then prepared, sequenced and analyzed using our Cell Ranger and Loupe Browser software tools.
+Added: The library preparation of the Chromium Single Cell Gene Expression Flex workflow is also compatible with the Chromium Connect.
Single Cell Immune Profiling
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This software allows researchers to identify cell type clusters based on gene expression and then layer T-cell and/or B-cell receptor sequence diversity directly onto that visualization, enabling users to easily derive biological meaning from these two different data types.
−Removed: The following visualization is an example showing the simultaneous assessment of paired immune cell receptor information and gene expression in colorectal cancer cells.
+Added: The following visualization is an example showing the diversity of immune receptors and groupings into specific genes and sequences.
______________
−Removed: Overlay of gene expression and lg clonotypes for colorectal cancer cells visualized using Loupe Cell Browser.
−Removed: Light blue dots indicate an lg clonotype cell.
−Removed: Dark blue dots show the location of the most prevalent lg clonotype in the plasma cell cluster, with the table outlining the gene calls for the heavy (H) and lambda l light chain.
−Removed: The paired H and l chain V(D)J sequences are shown to the right and corresponding V(D)J nucleotides are color-coded (5’UTR:
−Removed: Feature Barcode can be used in combination with our Single Cell Immune Profiling solution, adding significant multi-omic functionality.
+Added: With Loupe V(D)J Browser, you can explore the diversity of immune cell receptors and see how they are related.
+Added: The software displays groups of similar receptors and explores specific genes and sequences.
+Added: Feature Barcode can be used in combination with our Single Cell Immune Profiling solution, adding significant multiomic functionality.
Importantly, this functionality allows users to determine the antigen that is bound by immune cells simultaneously with their gene expression.
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
−Removed: 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.
−Removed: In 2022, we launched our Barcode Enabled Antigen Mapping (BEAM) solution, to be used in combination with our Chromium Single Cell Immune Profiling solution.
−Removed: 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.
−Removed: 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.
+Added: 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 and to assist researchers in constructing an immune map of receptor-antigen targeting rules.
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 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.
+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 analyze 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.
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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.
−Removed: ATAC–seq was pioneered by researchers at Stanford University and intellectual property rights directed to ATAC-seq are exclusively licensed to us.
+Added: ATAC–seq was pioneered by researchers at Stanford University and intellectual
+Added: property rights directed to ATAC-seq are exclusively licensed to us.
ATAC-seq has now become an important tool in epigenetics and genome-regulation research.
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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.
−Removed: The following visualization is an example of plots showing open chromatin around genes that are specifically associated with certain cell types.
−Removed: ______________
−Removed: Open chromatin signals around marker genes are specifically associated with the cell type of expression.
−Removed: Plots show aggregate chromatin accessibility profiles for each cluster at several marker gene loci.
Our Chromium Single Cell ATAC solution has been adopted by a number of key opinion leaders.
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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 instrument to encapsulate these nuclei in GEMs.
+Added: In the workflow, users treat cell nuclei with transposase enzyme and then use a 10x 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.
Sequencing reads are analyzed using our Cell Ranger ARC software, which has been specifically designed to leverage data from both RNA and ATAC data, and visualized using our Loupe Cell Browser.
−Removed: 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 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.
−Removed: 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: The following visualization is an example of how chromatin accessibility from ATAC data can be linked with gene expression data in cells:
Sample preparation solutions .
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Spatial Transcriptomics utilized arrays having specialized probes on their surfaces that are encoded with the spatial position of the probe.
−Removed: In the Visium product workflow, a tissue sample is placed onto the array and reagents are added by the user to create barcoded molecules from the array probes and the biological material in the tissues.
+Added: In this workflow, a tissue sample is placed onto the array and reagents are added by the user to create barcoded molecules from the array probes and the biological material in the tissues.
This barcoded material encodes the spatial information that was contained in the probes.
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This product was used to identify heterogeneity in metastatic melanoma and to demonstrate that there was significantly more heterogeneity than could be predicted by manual pathology annotation.
−Removed: In an independent study of mouse and human amyotrophic lateral sclerosis samples, researchers were able to observe changes in RNA expression over the disease course, while preserving the understanding of those changes in the spatial context.
+Added: independent study of mouse and human amyotrophic lateral sclerosis samples, researchers were able to observe changes in RNA expression over the disease course, while preserving the understanding of those changes in the spatial context.
This allowed them to visualize the key changes that occur in brain regions before and during neuronal degeneration.
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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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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 Visium CytAssist is a compact, benchtop instrument that enables spatial profiling insights with broad sample access and 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: Regardless of the sample type, sectioning, sample preparation, staining by either hematoxylin and eosin (H&E) or immunofluorescence (IF), and 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 Spatial 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 Spatial Gene Expression slide.
The remaining steps, starting with probe extension, follow the standard Visium for FFPE workflow outside of the instrument.
Data is visualized using our software tools.
−Removed: 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.
+Added: In 2023, we launched the Visium CytAssist Spatial Gene and Protein Expression assay, introducing the capability to combine whole transcriptome analysis, protein detection and high resolution imaging from the same slide using the Visium CytAssist.
+Added: The core of this assay is the Human Immune Cell Profiling Panel, an optimized set of probe-conjugated antibodies designed to enable the sequencing read-out of protein expression, designed to overcome the challenges of traditional multiplexed protein detection such as spectral overlap and limitations of antibody host species.
+Added: This assay also supports customization of protein readout via the addition of user-conjugated antibodies, providing researchers with expanding opportunities to gain multiomic readouts from human FFPE tissues.
+Added: We intend to continuously innovate to provide enhanced resolution, performance, throughput and efficiency for our existing Visium Spatial Gene Expression products.
+Added: Analogous to the Chromium platform, we also aim to develop additional Visium-based applications to allow spatial interrogation of a broader range of biological analytes such as DNA, immune molecules, epigenetics and proteins.
Our Xenium platform
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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.
−Removed: This provides researchers with a detailed map of gene expression patterns without
−Removed: sacrificing resolution or target number.
+Added: This provides researchers with a detailed map of gene expression patterns without sacrificing resolution or target number.
Xenium uses circularizable probes specific to target transcripts followed by enzymatic amplification to create a target for fluorescent probe hybridization.
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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.
−Removed: 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: Our current panels include Human Breast, Human Brain, Human Lung, Human Multi-tissue, Human Colon, Human Skin, Mouse Brain and Mouse Tissue Atlassing Gene Expression Panels.
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.
−Removed: Each panel can also be customized with up to 100 genes.
+Added: Each curated panel can also be customized with up to 100 genes.
+Added: In addition, customers can purchase a fully custom panel for up to 500 genes.
The Xenium Analyzer instrument comes with onboard analysis capabilities to process image data, localize RNA signals and perform secondary analysis.
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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.
+Added: We have developed sophisticated and scalable software that completes our solutions which we provide to researchers generally free of charge.
Our analysis software transforms large amounts of raw data into usable results, giving researchers user friendly tools to dynamically explore these results.
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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 (when required), through analyzing and visualizing this information, to make obtaining biological answers as easy as possible.
−Removed: Our Chromium and Visium workflows operate with third-party sequencers that are widely available in research settings.
Our market opportunity
−Removed: According to industry sources, the worldwide life sciences research tools market totaled more than $67 billion in 2021.
+Added: According to industry sources, the annual worldwide life sciences research tools market totals more than $67 billion.
Our diverse products and solutions allow biologists to interrogate and understand biological systems at exceptional resolution and scale.
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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 $16 billion of the more than $67 billion global life sciences research tools market in 2021.
+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 annual global life sciences research tools market.
This $16 billion opportunity includes flow cytometry, sequencing, microscopy, high content imaging and sample preparation, among other tools.
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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
−Removed: 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: 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.
Our competitive strengths
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.
+Added: Our position as a leader in a large and growing industry.
Since launching our first product in mid-2015 through December 31, 2023, cumulatively we have sold 5,966 instruments and we serve thousands of researchers globally.
−Removed: 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: We have fostered deep relationships with many key opinion leaders and our customers include leading academic and translational researchers and biopharmaceutical companies around the world.
Our products are an important part of our customers’ workflow and a significant portion of them utilize more than one of our solutions.
Our technologies have become a vital tool for biological research.
−Removed: To date, more than 4,500 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.
+Added: To date, we estimate that more than 7,200 peer-reviewed articles have been published based on data generated using our products.
+Added: Our position as a leader 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.
Our proprietary technologies.
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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 700 issued or allowed patents and more than 1,050 pending patent applications as of December 31, 2022.
+Added: Further, many of these technological elements can be utilized
+Added: 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 970 issued or allowed patents and 1,220 pending patent applications as of December 31, 2023.
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.
+Added: Our intellectual property portfolio includes important patents and patent applications directed to single cell analysis, epigenomics, spatial analysis, in situ analysis and multiomics.
Our rigorous product development processes and scalable infrastructure.
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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.
−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 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 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, and our aim to enable superior performance at larger scale and lower cost.
+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 including by identifying means to drive prices lower to support researchers and expand the opportunity for single cell analysis, and to harness the emergence of spatial biology as a bridge between genomics and pathology.
We expect that our investments in research and development will allow us to increase our penetration of our accessible markets.
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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.
−Removed: 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.
−Removed: These customers are substantial and easily accessible and therefore represent an opportunity for future instrument sales.
+Added: A portion of our current laboratory customers do not 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
+Added: opportunity for future instrument sales.
We also intend to expand our existing geographic reach, both directly and through distributors.
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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 a dedicated global strategic sales, marketing and business development team to support the adoption cycle by biopharmaceutical companies.
+Added: We have a dedicated pharmaceutical sales, marketing and business development team to support the adoption cycle by biopharmaceutical companies.
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.
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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.
+Added: Over the years, we have developed, acquired or in-licensed technologies and associated intellectual property rights across a broad range of emerging areas within biology and life sciences.
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.
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 when combined with internal innovations formed the foundation for our 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 commercialized this technology with our BEAM-T product in 2022.
Peer-reviewed scientific publications using our products
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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.
−Removed: Recent publications describe, for example, the use of our products to:
−Removed: • Understand the heterogeneity driving treatment resistance in pancreatic ductal adenocarcinoma;
−Removed: • Characterize early kinetics in tumor-infiltrating and circulating immune cells in oral cancer patients treated with immune checkpoint blockade therapy in a clinical trial;
−Removed: • Investigate why human ovarian cancer is poorly responsive to immunotherapy;
−Removed: • 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
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Our research and development groups work together in cross-functional project teams, 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 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.
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These improvements may provide increased sensitivity to capture greater amounts of signal from biological analytes, allow broader types of biological samples to be interrogated with our solutions and increase the amount of biological information that can be obtained using our software.
−Removed: 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 starting sample types and biological information.
−Removed: 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.
−Removed: Develop new solutions for our Visium platform .
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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: Develop new solutions for our Xenium platform .
−Removed: 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: Develop new solutions for our platforms .
+Added: We plan to expand the range of solutions that are available on our Chromium, Visium and Xenium platforms to allow researchers access to new types of starting sample types and biological information.
Improve and develop new capabilities for our instruments .
−Removed: 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.
+Added: We plan to develop new capabilities that would improve the usability and increase the performance of our instruments.
Develop combined software and workflows across multiple solutions.
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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.
−Removed: We plan to do this for key solution combinations where the information obtained from the two solutions is highly complementary.
+Added: We plan to do this for key solution combinations where the information obtained from multiple solutions is highly complementary.
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 formed the basis of our Xenium platform.
Our research and development costs were $270.3 million and $265.7 million for the years ended December 31, 2023 and 2022, respectively.
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Commercial team
−Removed: Since launching our first product in mid-2015, we have expanded our commercial operations and now sell our products in 50 countries.
+Added: Since launching our first product in mid-2015, we have expanded our commercial operations and now sell our products in over 50 countries.
Our customers primarily include academic, government, biopharmaceutical, biotechnology and other institutions focused on life sciences research.
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As of December 31, 2023, our commercial organization consisted of 450 full time employees, many with PhD degrees and many with significant industry experience.
−Removed: We sell our products through third-party distributors in Asia, certain regions of Europe, Oceania, South America, the Middle East and Africa.
−Removed: For both the years ended December 31, 2022 and 2021, no single customer, including distributors, represented greater than 10% of our business.
−Removed: For both the years ended December 31, 2022 and 2021, sales to academic institutions represented approximately 61% and 60% of our direct sales revenue, respectively.
+Added: We sell our products through third-party distributors in Asia, certain regions of Europe, Oceania, Central America, South America, the Middle East and Africa.
+Added: For the years ended December 31, 2023 and 2022, no single customer, including distributors, represented greater than 10% of our business.
+Added: For the years ended December 31, 2023 and 2022, sales to academic institutions represented approximately 65% and 61% of our direct sales revenue, respectively.
We expect that sales to biopharmaceutical companies will represent a growing proportion of our revenue in the future.
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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
−Removed: instruments to accelerate the adoption of new solutions.
+Added: As our customer base has grown, we have been able to sell more instruments to accelerate the adoption of new solutions.
Over half of our customers purchased our consumables relating to more than one of our solutions in both the years ended December 31, 2023 and 2022.
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These successes often result in publications which can drive increased public awareness and further market adoption.
−Removed: Since our first product launch in 2015, there have been more than 4,500 publications by researchers using data generated by our products.
+Added: Since our first product launch in 2015, we estimate that there have been more than 7,200 publications by researchers using data generated by our products.
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.
−Removed: 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.
+Added: Due to the pricing of our instruments and consumables, the buying decision is often 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.
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.
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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.
−Removed: 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.
+Added: 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 marketing.
We supplement these traditional marketing efforts by fostering an active online community of users of our products consisting of communities, forums and blogs with internally generated and user-generated content.
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Suppliers and manufacturing
−Removed: The majority of our consumable products are manufactured in-house at our facilities in Singapore and in Pleasanton, California.
−Removed: These manufacturing operations include:
−Removed: gel bead generation, surfactant synthesis and emulsion oil formulation, reagent formulation and tube filling, microfluidic chip manufacturing, kit assembly and packaging as well as analytical and functional quality control testing.
−Removed: Our Pleasanton, California and Singapore manufacturing operations are ISO 9001:2015 certified, which covers design, development, manufacturing, distribution, service and sales.
−Removed: We obtain some components of our consumables from third-party suppliers.
−Removed: While some of these components are sourced from a single supplier, we have qualified second sources for some, but not all, of our critical reagents, enzymes and oligonucleotides.
+Added: Our Pleasanton, California and Singapore manufacturing operations are ISO 9001:2015 certified, which covers design, development, manufacturing, distribution, service and sales, and we intend to seek similar certification for our newly acquired operations in Taiwan.
+Added: We obtain some components of our instruments and consumables from third-party suppliers.
+Added: While some of these components are sourced from a single supplier, we have qualified second sources for some, but not all, of our components including critical reagents, enzymes and oligonucleotides.
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.
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.
−Removed: 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.
+Added: The majority of our consumable products are manufactured at our facilities.
+Added: These manufacturing operations include, among other operations, gel bead generation, surfactant synthesis and emulsion oil formulation, reagent formulation and tube filling, certain of our microfluidic chips, kit assembly and packaging as well as analytical and functional quality control testing.
+Added: We outsource manufacturing for our Chromium, Visium CytAssist and Xenium 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.
+Added: We perform optical and final assembly, instrument integration and testing of our Xenium instrument in-house.
Human Capital
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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: 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, 2023, we employed a total of 1,259 individuals, 924 of whom were employed in the United States and 335 of whom were employed outside the United States.
As of December 31, 2023, our employees included 451 in research and development, 450 in sales, marketing and support, 196 in general and administrative and 162 in manufacturing, many of whom hold PhDs in their respective disciplines.
Additionally, most of our senior management team and the members of our board of directors hold PhDs and/or other advanced degrees.
−Removed: Our Company's scientific expertise is therefore embedded within the management team and throughout the organization.
+Added: Company's scientific expertise is therefore embedded within the management team and throughout the organization.
We are very proud to say that some of the world-leading experts in chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering work and thrive at 10x.
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employees are represented by a labor union or covered under a collective bargaining agreement.
−Removed: In our international territories, apart from standard industry-wide labor unions and compulsory collective bargaining agreements, such as in Italy where we have fewer than ten employees, none of our employees are represented by a labor union or subject to a collective bargaining agreement.
+Added: In our international territories, apart from standard industry-wide labor unions and compulsory collective bargaining agreements, none of our employees are represented by a labor union or subject to a collective bargaining agreement.
We consider our relationship with our employees to be positive.
−Removed: The life sciences market is highly competitive.
+Added: The life sciences industry is highly competitive.
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: We also compete with companies that offer existing tools and technologies for life science research, such as bulk sequencing, flow cytometry, PCR, immunofluorescence, immunohistochemistry and other imaging and cell-based assays, that are replaced by our products.
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.
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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 expect new competitors to emerge and the intensity of competition to increase.
−Removed: 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.
−Removed: We believe our customers favor our products and company because of these differentiators.
+Added: We expect new competitors to continue to emerge and the intensity of competition to continue to increase.
+Added: We believe we are differentiated from our competitors for many reasons, including the capabilities and performance of our products, our advanced proprietary technologies protected by substantial intellectual property, our rigorous product development processes and scalable infrastructure and our superior customer experience and multidisciplinary teams.
For further discussion of the risks we face relating to competition, see the section titled “ Risk Factors—Risks related to our business and industry—Our industry is highly competitive.
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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.
−Removed: Unlike the EU IVDD, the EU IVDR is directly
−Removed: applicable in all EU member states without the need for member states to implement into national law.
+Added: 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.
This aims at reducing the risk of discrepancies in interpretation across the different European markets.
The EU IVDR became applicable on May 26, 2022.
−Removed: 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: 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
+Added: body, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
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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.
−Removed: 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: Consequently, products labeled as RUO are essentially not subject to compliance with the EU IVDR requirements such as conformity with general, safety and performance requirements laid down in the EU IVDR.
Depending on the products in question, other regulations may be applicable to the RUO products.
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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 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: However, all IVDs placed on the EU market must meet general, safety and performance requirements laid down in Annex I to 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.
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.
−Removed: 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.
+Added: Compliance with general, safety and performance 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.
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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 700 issued or allowed patents and more than 1,050 pending patent applications as of December 31, 2022.
+Added: Worldwide we own or exclusively in-license over 970 issued or allowed patents and 1,220 pending patent applications as of December 31, 2023.
We also license additional patents on a non-exclusive and/or territory restricted basis.
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The Harvard Agreement is projected to expire in 2034.
−Removed: In connection with our acquisition of Spatial Transcriptomics, we are required to make contingent payments to the sellers based on revenue from sales of Spatial Transcriptomics products and Visium products, for the years ended December 31, 2019 through December 31, 2022.
−Removed: These contingent payments are equal to a percentage in the teens multiplied by such revenue.
+Added: In connection with our acquisition of Spatial Transcriptomics Holdings AB (“Spatial Transcriptomics”), we were required to make contingent payments to the sellers based on revenue from sales of Spatial Transcriptomics products and Visium products, for the years ended December 31, 2019 through December 31, 2022.
+Added: These contingent payments were equal to a percentage in the teens multiplied by such revenue.
In September 2020, we entered into an exclusive license agreement with The Board of Trustees of the Leland Stanford Junior University (“Stanford”), pursuant to which we in-license exclusive, worldwide rights under certain of Stanford’s patents and patents applications directed to ATAC-seq technology in all field of use (“Stanford Agreement”).
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The Stanford Agreement is projected to expire in 2038.
−Removed: For the years ended December 31, 2022 and 2021, we made aggregate contingent and royalty payments under the Spatial Transcriptomics acquisition agreement, Stanford license agreement and Harvard license agreement, collectively, of less than $12.8 million and $12.0 million , respectively.
−Removed: We expect the size of these payments to grow as our business grows.
+Added: For the years ended December 31, 2023 and 2022, we made aggregate contingent and royalty payments under the Spatial Transcriptomics acquisition agreement, Stanford license agreement and Harvard license agreement, collectively, of approximately $15.4 million and $12.8 million, respectively.
+Added: Other than payments under the Spatial Transcriptomics acquisition agreement, we expect the size of these payments to grow as our business grows.
The patents we own expire beginning in 2030 and the patents we exclusively in-license expire beginning in 2028.
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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
−Removed: of personal data, including health-related data.
−Removed: 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.
+Added: In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.
+Added: Privacy and security laws, regulations and other obligations are constantly
+Added: 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.
Corporate information
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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.