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Seer, Inc.CIK 0001726445 · Lab Analytical Instruments
Our mission is to imagine and pioneer new ways to decode the biology of the proteome to improve human health. Through our product, the Proteograph® Product Suite (Proteograph), we provide researchers with unbiased, deep, rapid and large-scale access to the proteome, enabling biological discovery… About this business →
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About Seer, Inc.
Source: Item 1 (Business) from the 10-K filed March 2, 2026. Description as filed by the company with the SEC.
Item 1. Business
Overview
Our mission is to imagine and pioneer new ways to decode the biology of the proteome to improve human health. Through our product, the Proteograph® Product Suite (Proteograph), we provide researchers with unbiased, deep, rapid and large-scale access to the proteome, enabling biological discovery that has historically been impractical. With our pioneering proprietary engineered nanoparticle (NP) technology and the Proteograph Product Suite, we provide the most complete, precise, and scalable platform for deep, unbiased proteomics to power population-scale studies and data-driven biology.
Proteins are the functional drivers of biology and the primary targets of most approved drugs. Unlike DNA, which is largely static over an individual’s lifetime, the proteome is dynamic, reflecting real-time biological processes, disease states, and responses to therapeutic intervention. However, the molecular diversity of the proteome, arising from transcription, RNA processing, translation, post-translational modifications (PTMs), and protein–protein interactions, has historically limited researchers’ ability to comprehensively characterize protein biology at scale. Traditional proteomic approaches have forced researchers to choose between depth and throughput: unbiased methods that lack scalability, or scalable methods that are targeted, epitope-dependent, and unable to resolve protein variants with sufficient precision.
The Proteograph was developed to eliminate this trade-off. By enabling peptide-level resolution across the length of proteins in complex samples such as plasma, the Proteograph allows researchers to detect protein isoforms, PTMs, and variant peptides without reliance on predefined binding epitopes. This approach reduces measurement artifacts associated with affinity-based technologies and enables accurate interrogation of protein diversity that is critical for understanding disease biology, biomarker discovery, and therapeutic targeting.
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The Proteograph Product Suite is a comprehensive solution consisting of consumable assays, an automation instrument, and data analysis software. Our latest product innovations, the Proteograph ONE assay and the SP200 automation instrument, launched in May 2025 and have resulted in approximately a ten-fold improvement in throughput relative to our first-generation assay, enabling processing of more than 1,000 samples per week. The Proteograph generates significantly more data per sample and more measurements per protein than other commonly used proteomic technologies, producing dense, high-resolution datasets designed to enable AI-driven scientific discovery.
The Proteograph is increasingly being adopted by proteomics researchers, and also by genomics-focused researchers seeking to bridge the gap between genetic variation and biological function. Advances in next-generation sequencing have resulted in the identification of over one billion human genetic variants, yet only a small fraction has been functionally characterized. This disparity reflects, in part, the historical imbalance between the availability of genomic data and high-quality proteomic data. By enabling scalable, deep, unbiased measurement of the proteome, the Proteograph adds essential functional context to genomic information and supports integrative, multi-omics approaches to understanding human disease.
Since our commercial launch in 2021, we have served more than 190 customers across over 20 countries, including leading academic institutions, biopharmaceutical companies, biobanks, and clinical research organizations. For the first time, our customers are conducting population-scale unbiased proteomic studies involving tens of thousands of samples, quantifying thousands of proteins and hundreds of thousands of peptides and generating data suitable for large-scale statistical analysis and to power emerging biological AI foundation models.
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The differentiation and unmatched performance of the Proteograph have been demonstrated in a growing body of third-party evidence, including 70 peer-reviewed publications, preprints, and reviews as of December 31, 2025. These studies span diverse applications, including protein quantitative trait locus (pQTL) mapping, identification of disease-associated protein variants, aging biology, xenotransplantation, and biomarker discovery in complex diseases. In multiple studies, researchers have shown that peptide-level resolution enabled by the Proteograph revealed biologically meaningful signals that are obscured or mischaracterized by affinity-based proteomic methods, including false associations driven by protein-altering variants.
The Proteograph has also supported the development of translational and clinical research applications. For example, PrognomiQ, a pioneering multiomics diagnostic company spun out of Seer in 2020, has leveraged unbiased, deep proteomics generated by the Proteograph to develop a blood-based test for early lung cancer detection, demonstrating the potential clinical relevance of comprehensive proteomic datasets. We believe these collaborations highlight the role of unbiased proteomics as a foundational input for multi-omics, AI-driven precision medicine.
With a growing installed base, increasing utilization, expanding population-scale studies, and continued investment in product innovation, we believe Seer is well positioned to play a central role in enabling the next generation of data-driven biology and AI-driven precision medicine.
Figure 1: Proteins are the functional molecules of biology and represent the primary targets of most approved drugs. Unlike DNA, which is largely static over an individual’s lifetime, proteins are dynamic and reflect real-time biological states influenced by genetics, environment, disease, and therapeutic intervention. As a result, proteomic data has the potential to provide insights into disease mechanisms, patient stratification, and treatment response that are not accessible through genomic or transcriptomic approaches alone.
Complexity of the Proteome
The human proteome is dynamic, diverse and complex, with approximately 23,000 genes giving rise to over one million protein variants. As shown in Figure 2 below, these variants arise from various mechanisms, including alternative splicing of RNA transcripts, genetic variations that alter the amino acid sequence of the protein, and post-translational modifications such as phosphorylation and glycosylation. It is estimated that our approximately 23,000 genes give rise to approximately 70,000 protein isoforms through alternative splicing. At a population level, a much larger number of protein isoforms exist because of genetic variants and somatic variants that alter RNA processing. Protein variants can have vastly different biological functions and be expressed in different tissues within the same individual. For example, two isoforms of the protein encoded by CD99L2 have different interacting proteins and those two proteins’ networks are related to distinct diseases (Yang et al.).
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A study by Backman et al. published in Nature revealed the genomic variation identified in a cohort of approximately 455,000 participants of the UK Biobank exome sequencing study. The study identified a vast amount of protein variation, including almost nine million protein variants, of which more than six million are potentially deleterious and 915,289 are protein loss-of-function variants. On the individual level, each participant had, on average, 9,506 protein variants, of which 2,945 were potentially deleterious and 214 were loss-of-function variants. However, these variants were only identified at the genomic level and did not account for alternative splicing or post-translational modifications. Considering these additional sources of protein variants, the actual number of protein variants at both individual and population-wide levels is significantly higher.
These findings emphasize the unmet need to understand protein variants at the peptide-level and underscore how little is currently known about the complexity of the proteome. We believe understanding protein variation at this level could revolutionize how we diagnose, treat, and monitor diseases.
Figure 2: Functional diversity exists through modifications and interactions of different molecules, from static indicators like the genome to increasingly numerous and complex indicators like the proteome and interactome. Modified from Bludau et al
The Importance of Unbiased, Peptide-level Resolution Proteomics
Novel Biological Insights Enabled by the Proteograph
The ability to perform unbiased proteomics at scale has transformed biological analysis. In genomics, unbiased sequencing of the genome enabled discovery of novel content, creating new end-market opportunities in basic research and discovery, translational research and clinical applications, including early cancer detection, recurrence monitoring and non-invasive prenatal testing.
Similar to genomics, researchers are using the Proteograph to discover and access novel proteomic content that was previously inaccessible. As a result, new biological insights are emerging that would otherwise not be possible without the peptide-level resolution provided by the Proteograph.
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Disease-associated protein detection with unbiased, peptide-level resolution. In a 2025 study by Pietzner et al., deep plasma proteomic profiling in over 1,400 individuals of South Asian ancestry identified more than 1,200 significant genetic associations with circulating proteins, approximately half of which were novel, as shown below in Figure 3. Integrating these data with large-scale human genetics and disease endpoints, the authors prioritized 21 proteins with strong evidence for a causal role in 44 diseases. Notably, the Proteograph's peptide-level measurements revealed a previously unrecognized role for the immunoglobulin light-chain variable protein IGLV3-21 in Graves’ disease, supported by genetic colocalization, immune cell–specific expression, and disease specificity. These findings demonstrate how peptide-level resolution enabled by the Proteograph can reveal novel protein–disease mechanisms and biomarkers that directly inform disease biology and therapeutic target discovery.
Figure 3. Over 1,200 variant protein associations were detected, about half of which were novel. The Proteograph detected a high number of proteins and pQTLs previously not found by affinity-based technologies. Additionally, because of the Proteograph, scientists were also able to confirm the absence of some proteins in plasma that had lost their function.
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Identification of false-positive pQTLs from affinity-based proteomic methods due to epitope effects. Peptide-level resolution is especially important in proteogenomic analyses, where the presence of allelic variants within proteins confounds affinity-based proteomics methods. In a study published in Nature Genetics in November 2025, Karsten Suhre and colleagues in collaboration with our team conducted the first deep, large-scale mass spectrometry (MS)-based genome-wide association search (GWAS) for protein quantitative trait loci (pQTLs) (Suhre et al.). In addition to discovering 252 pQTLs across a discovery cohort of 1,260 American participants and a replication in 325 individuals from Asia with diverse ethnic backgrounds, Suhre et al. investigated 200 of the strongest cis-pQTLs previously identified using two separate leading affinity-based technologies, which were applied to a cohort of 36,000 Icelandic participants and a cohort of 55,000 UK participants, respectively. Suhre et al. found that up to one third of the affinity proteomics pQTLs may be affected by epitope effects and, therefore, be false positive identifications due to the presence of protein allelic variants that disrupt or alter the binding of the affinity reagent to the protein surface. Another third of the 200 analyzed pQTLs were confirmed by Seer-based MS proteomics. These findings are consistent with the hypothesis that genetic variants induce changes in protein expression. This study demonstrated the ability of peptide-level resolution in distinguishing between true pQTLs and putatively false identifications of affinity-based proteomics technologies, suggesting that many more pQTLs remain to be discovered using MS-based platforms.
Figure 4: The ability of peptide-level resolution to validate affinity-based pQTL identifications. The 100 strongest pQTLs identified in a cohort of 55,000 participants in UK Biobank are scored by Seer MS data obtained in a discovery cohort of 1,260 American participants and a replication cohort of 325 Asian participants. In the x-axis, each of the 100 pQTLs is sorted by statistical significance in UK Biobank, left being the most significant; in the y-axis, each pQTL is scored according to peptide-level evidence in Seer data, with 1.0 being the highest level of evidence. The pQTLs marked green were found by another affinity-based platform performed in a cohort of 36,000 Icelandic participants; such pQTLs are highly reliable, being independently discovered in two cohorts by two technologies. Almost all highly reliable pQTLs are scored highly by Seer data; conversely, pQTLs that are scored low are likely to be false discoveries, potentially due to epitope effects induced by the presence of protein allelic variants that alter the binding of the affinity reagent to the protein surface.
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Biomarker discovery in multi-omic diagnostic test development. The Proteograph is also demonstrating significant value in the development of multi-omic diagnostic tests. Scientists at PrognomiQ conducted a large case-control study focused on individuals at elevated risk for lung cancer. Using the Proteograph Product Suite, researchers measured over 13,000 proteins from plasma samples collected from 2,513 individuals. These proteomic measurements alone achieved an area under the curve (AUC) of 0.91, and when combined with transcriptomic and metabolomic measurements, performance improved to an AUC of 0.96.
In November 2025, PrognomiQ launched ProVue Lung, a proteomics-based laboratory developed test to aid in the early detection of lung cancer. ProVue Lung has been shown to detect lung cancer with 85% sensitivity and 55% specificity. Importantly, Stage I lung cancer is detected at 81% sensitivity, when treatment is most effective. The test also has a clinically informative negative predictive value (NPV) of greater than 99.8 percent. We believe these results illustrate the potential of Proteograph-enabled proteomics to contribute meaningfully to the development of high-performance blood-based diagnostic tests.
Potential patient stratification in Alzheimer’s and other dementia-related diseases. Within translational research applications, we believe the Proteograph is accelerating the transition from discovery research to clinical relevance. Using funding from a Small Business Innovation Research grant from the National Institute on Aging, researchers from Seer and Massachusetts General Hospital conducted a longitudinal study analyzing approximately 1,800 plasma samples from individuals with cognitive decline, including Alzheimer’s disease, and matched controls. The study identified 138 proteins that were differentially abundant between affected individuals and controls, the majority of which had not been previously associated with Alzheimer’s disease. Researchers further identified subsets of proteins associated with rates of cognitive decline, supporting the potential development of protein-based risk or progression scores. One such example is shown in Figure 5 below. Higher abundance of this protein is associated with greater probability of cognitive decline. We believe studies of this scale and depth are enabled by the ability of the Proteograph Product Suite to generate unbiased proteomic data across large sample cohorts.
Figure 5: Shows the probability of no decline as a function of follow up time. Higher levels of the protein are associated with higher probability of decline.
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Identification of circulating aging signatures in model organisms. Within biomarker discovery and translational aging research, the Proteograph is enabling the identification of clinically relevant, cell-type–specific protein signatures that link fundamental senescence biology to human health outcomes. In a 2025 Nature Aging study, Olinger et al. used Proteograph proteomic data to deeply characterize the senescence-associated secretory phenotype (SASP) of human monocytes and assess its relevance to aging in large human cohorts. By applying the Proteograph platform to serum-supplemented cell culture, the authors identified over 5,000 human proteins and 14,000 peptides, more than tripling peptide coverage compared to standard workflows, and uncovered thousands of proteins increased in the monocyte SASP, including signaling factors not previously linked to immune cell senescence.
Translating these findings to human plasma, the authors mapped monocyte SASP proteins to proteomic data from 1,060 participants in the Baltimore Longitudinal Study of Aging. Machine-learning models based on SASP-derived protein panels predicted multiple age- and obesity-associated clinical traits, including body fat composition, lipid levels, inflammation, and mobility, with strong test-set performance. These associations were independent of age and replicated in the InCHIANTI aging cohort. A high-impact panel of 21 SASP proteins further stratified individuals by a composite senescence burden score associated with metabolic dysfunction and functional decline. Together, these results demonstrate how peptide-level resolution enabled by the Proteograph reveals clinically actionable senescence biology and supports the development of blood-based biomarkers of biological aging.
Figure 6: A composite senescence burden score derived from circulating senescence-associated proteins is associated with multiple health indicators in an aging population. Higher senescence burden corresponds to higher BMI and inflammation (CRP) and lower HDL levels and walking pace, indicating a relationship between proteomic signatures and metabolic and functional health across individuals.
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Paradigm Shift to AI-driven Biological Discovery
Biological research is undergoing a shift from hypothesis-driven experimentation toward data-driven discovery at population scale. Advances in artificial intelligence and machine learning have increased the ability to extract biological insight from large, multimodal datasets; however, the performance and reliability of these models depend fundamentally on the quality, quantity, and resolution of the underlying biological data. In proteomics, this requirement is particularly acute, as many clinically relevant biological signals arise from protein variants, post-translational modifications, and dynamic changes in protein abundance that are not captured by genomic or transcriptomic measurements alone.
We believe that AI-driven biological foundation models require dense, high-resolution proteomic datasets that include multiple measurements per protein and sufficient scale to support robust statistical learning. As shown in Figure 7 below, the Proteograph platform is designed to generate substantially more data per sample than other commonly used proteomic technologies, producing tens of thousands of protein measurements per sample and multiple peptide-level measurements per protein. This increased data density, combined with population-scale throughput, enables the generation of large, high-quality proteomic datasets suitable for training and validating AI models that aim to uncover novel biological relationships, disease mechanisms, and therapeutic targets.
Figure 7: The Proteograph platform generates substantially more proteomic data per sample than other commonly used proteomic technologies. By producing over 77,000 data measurements per sample and multiple peptide-level measurements per protein on average, we believe the Proteograph enables higher-density datasets that support robust statistical analysis and data-driven discovery.
Our Product and Technology
The Proteograph Product Suite is an integrated solution consisting of consumables, an automation instrument, and data analysis software designed to enable unbiased, deep proteomic analysis at scale in a matter of hours. The Proteograph workflow is designed to be efficient and easy to use, leveraging common laboratory instrumentation to support adoption in both centralized and decentralized research settings. We believe this approach makes deep, unbiased proteomics accessible to a broad range of laboratories.
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In May 2025, we launched our next generation assay, Proteograph ONE, along with the SP200 automation instrument, further expanding the scalability and throughput of the Proteograph Product Suite.
Figure 8: Proteograph Product Suite comprises consumables, an automation instrument, and software.
Consumables
The Proteograph consumables consist of our proprietary engineered nanoparticles (NPs) and all other reagents required to process biological samples in an automated workflow on our automation instrument. These consumables are designed to enable unbiased, reproducible sampling of intact proteins across the dynamic range of the proteome while eliminating the need for complex and labor-intensive enrichment workflows.
Our engineered NPs are designed to selectively and reproducibly bind intact proteins when exposed to a biological sample, forming a protein “corona” on the nanoparticle surface (shown below in Figure 9). Protein binding is driven by the physicochemical properties of the nanoparticle surface, the abundance of proteins in the sample, and protein–protein interactions among bound proteins. This process occurs rapidly and reaches equilibrium within minutes, enabling robust and reproducible sampling without prior knowledge of proteome composition or the need to target specific proteins. In combination with an unbiased mass spectrometry (“MS”) readout, this approach captures molecular information at the peptide level, including protein variants.
Figure 9: Nanoparticles allow unbiased interrogation of proteoform diversity. Our nanoparticle technology leverages engineered physicochemical properties to reproducibly bind to proteins without prior knowledge, forming a protein corona.
By incorporating our engineered NPs into the Proteograph assay, we achieve representative sampling from high- to low-abundance proteins across a wide range of sample types, including biofluids, cell lysates, and tissue homogenates. We believe this approach replaces traditional, complex laboratory workflows required for deep, unbiased proteomics and enables scalable, high-throughput studies. We have characterized our technology and its performance in three peer-reviewed publications: Nature Communications (Blume et al.), PNAS (Ferdosi et al.), and Advanced Materials (Ferdosi et al.).
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Our third-generation assay, Proteograph ONE, launched in May 2025, significantly increases sample throughput across both the Proteograph workflow and downstream MS analysis, delivering more than a 3.6x increase compared to the Proteograph XT assay launched in 2023 and approximately a 10x increase compared to the original Proteograph assay launched in 2021. Proteograph ONE uses a single well of NPs along with assay buffers and reagents for protein lysis and digestion, peptide purification, peptide quantification, and reconstitution of lyophilized materials. The assay enables the parallel processing of up to 80 samples on a single 96-well plate in under five hours, with the remaining wells reserved for integrated quality control samples to support consistent performance and troubleshooting.
In addition to Proteograph ONE, we launched the Proteograph DIRECT assay in 2025. The DIRECT workflow provides an automated approach for direct digestion of samples for bottom-up LC-MS proteomic analysis and enables processing of up to 80 samples per day. Methods for tissue lysate and cell lysate samples can also be run using the DIRECT workflow.
Automation Instrument
The Proteograph workflow is executed in an automated manner on our SP200 automation instrument, a custom-configured, industry-standard liquid handling workstation launched in May 2025 as the next iteration of our automation instrument. The SP200 instrument is designed to support population-scale studies through highly parallel sample processing with approximately 60 minutes of setup time. The workflow is controlled through our Instrument Control Software (“ICS”), which manages assay execution on the SP200.
Software
The Proteograph Analysis Suite (“PAS”) is a data analytics software suite designed to support quality control, data management, and interpretation of Proteograph output. PAS is currently offered as a cloud-based solution and, in the future, may be made available through localized deployment options to accommodate different customer requirements.
PAS provides a predefined and scalable workflow that integrates publicly available MS data analysis tools with our proprietary analysis capabilities. It also includes a dedicated proteogenomics workflow that maps peptide-level data to genomic data to identify sample-specific variant peptides not captured in canonical reference databases. PAS provides interactive visualizations and tables to support data exploration, including views of peptide-to-gene relationships, protein domains, and functional regions.
During 2025, PAS updates included enhancements to data handling capabilities, more granular user permission controls to support service-provider workflows, and expanded system capacity to support studies involving up to approximately 10,000 samples. We expect to continue expanding PAS functionality as we extend our product portfolio.
Proteograph Product Suite Performance
The Proteograph Product Suite provides five essential capabilities: (i) broad protein sampling with peptide-level resolution; (ii) deep coverage; (iii) accurate and precise measurement; (iv) reproducibility and (v) scalability for high-throughput studies. We believe that our integrated solution is the only product in the market that combines all these technical and operational capabilities. Furthermore, we rigorously measure and evaluate each of these technical attributes, as we describe below.
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Breadth of protein sampling. This capability refers to conducting unbiased sampling of the proteome. The Proteograph ONE assay contains uniquely engineered NPs that selectively capture thousands of distinct intact proteins from a biosample based on their abundance and affinity for the NP surface. This sampling capability is particularly strong in complex biofluids such as plasma. Our unique NPs capture significantly more proteins than current methods of unbiased proteomic analysis. As shown in Figure 10 below, Proteograph ONE detects approximately 7x proteins compared to neat plasma on the Orbitrap Astral MS from Thermo Scientific. Additionally, in a customer study of over 800 samples, approximately 9,000 proteins were identified on Proteograph ONE.
Unlike affinity-based platforms, which typically generate a single measurement per protein, the Proteograph produces multiple peptide-level measurements per protein, averaging approximately 11 measurements per protein. As a result, a single sample can yield >77,000 data measurements. This depth of measurement increases the informational content of each experiment and supports scalable analyses across large datasets, including applications such as training emerging biological foundation models and enabling the discovery of novel biological insights not possible with affinity-based platforms.
In another study performed by PrognomiQ across a set of 2,840 plasma samples, approximately 13,000 proteins were identified.
Figure 10: Proteograph ONE demonstrates a 7.0x expansion in depth of coverage compared to neat plasma. In a recent customer study across more than 800 plasma samples, approximately 9,000 proteins were identified.
The Proteograph ONE assay is not limited to a defined set of proteins, and samples across the dynamic range of proteins and protein variants that may be present in biosamples. We have exemplified the utility of the Proteograph in studying secreted proteins across several different sample types, including cell or tissue homogenates, blood or blood components (such as plasma or serum), urine, saliva, cerebrospinal fluid, synovial fluid and conditioned media. Importantly, the Proteograph ONE assay protein data is obtained using an MS detector, which is the gold standard for proteomics, and data is conventionally reported with a less than one percent False Discovery Rate (FDR). This means that the reported proteins are identified with very high confidence.
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Depth of coverage. The Proteograph can quantify the proteome across a wide dynamic range of protein abundance. Figure 8 compares the depth of coverage of our assay with that of neat plasma and demonstrates that the Proteograph assay detected >4-fold more proteins cataloged in the Human Plasma Proteome Project (HPPP).
Figure 11: Protein identifications from identical samples processed with (1) Proteograph ONE Workflow paired with Leading MS, (2) Direct Digestion paired with Leading MS were mapped toward the HPPP database. The protein estimated concentrations were taken from HPPP data central (https://peptideatlas.org/hupo/hppp/) and protein concentration are rank ordered in decreasing abundance from left to right.
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Accuracy of measurement. This capability measures how close the measured abundance of a protein is to the true abundance in a sample. The measurement of the true abundance of a large number of proteins at the protein variant level at scale is not possible, so we use the ratio of abundances in two samples to demonstrate the accuracy of protein abundance measurement. We demonstrate the accuracy of protein abundance measurement by mixing two different plasmas in different ratios and measuring the relative MS signal intensity. By spiking human plasma with bovine plasma, the Proteograph can detect and quantify peptides that are unique to the bovine proteome. Peptides differ between the two species because of genetic differences that result in detectable changes at the amino acid level. By mixing the two plasma samples, the Proteograph can make measurements across thousands of peptides, highlighting the real-world accuracy of the Proteograph Product Suite. As shown below in Figure 12, bovine plasma was spiked into human plasma to create samples with different bovine to human ratios (1:11, 1:5, and 1:3). From there, fold-changes between spiked sample pairs were measured and compared against the known values (1.5X, 2X, and 3X). The Proteograph ONE workflow accurately measured the spike-in samples, collecting observed fold-changes close in value to the actual changes (1.56X, 1.95X, and 3.09X) and those collected by direct digest.
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Figure 12: (Top) Three representative pairs of spiked-in samples and the expected fold-changes of bovine proteins concentration in these pairs. (Bottom) Distribution of observed fold-changes of bovine proteins for 3 selected comparisons of spiked-in samples. The color indicates the data source: protein identifications unique to direct digestion (gray), protein identifications shared between the Proteograph ONE workflow and direct digestion (purple), or protein identifications unique to the Proteograph ONE workflow (teal). The horizontal dashed lines indicate the expected foldchanges.
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Reproducibility of measurement in large studies. Reproducibility, also referred to as precision, is a measure of the consistency of protein abundance measurements (i.e., MS measured intensity) between repeated measurements of the same sample. A higher reproducibility indicates lower noise, which reduces the number of samples required to observe a true fold change in the study. Reproducibility is usually measured as the coefficient of variation (CV%), which is the standard deviation divided by the mean multiplied by 100. A lower CV% represents a more precise measurement. The CV across individual components of the workflow, including the Proteograph instrument and the MS instrument, aggregate to form the overall CV% of the workflow.
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Performance was also assessed through CVs for protein groups intensity and peptide intensity. The intra-plate and inter-plate CVs for protein group intensity were 13.4% and 16.1%, respectively (Figure 13, left). These CVs are similar to or better than those collected with other methods and commercial platforms. With the intra-plate CV at 17.2% and inter-plate CV at 21%, peptide data showed a similar albeit slightly elevated trend (Figure 13, right). This increase in CV is consistent with expectations for median peptide CV compared to median protein group CV. To further pressure test CV results, plates were also processed by two different SP200 automation instruments. When combining inter-instrument analysis with inter-plate comparisons, protein group (16.7%) and peptide (21.8%) CVs remained low, only increasing slightly (Figure 13). Collectively, median protein group and peptide CVs within and between plates and SP200 instruments indicate the Proteograph ONE workflow provides excellent precision and experimental reproducibility, even when varying days, plates, and instruments.
Figure 13: Control pooled plasma was run in replicates on three different experimental settings: (teal) intra-plate, intra-Proteograph (comparison was made within the same plate and same SP200 automation instrument), (gray) inter-plate, intra-Proteograph (comparison was made with the same SP200 automation instrument, but different processing plates), and (purple) inter-plate, inter-Proteograph (comparison was made with different SP200 automation instruments and different processing plates). The label-free intensity coefficient of variation (CV %) was plotted for (left) Protein groups, and (right) Peptides, respectively. Median CV % was plotted and annotated directly on the plot, with dotted line denoting 20% CV.
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Scalability. The Proteograph Product Suite enables rapid and large-scale proteomic sample processing in an approximately five-hour workflow, compared to other unbiased solutions that can take days to weeks. With our current assay, we can process 80 samples in a single run of the Proteograph SP200 instrument. Therefore, a single Proteograph Product Suite can process over 1,000 samples per week and over 50,000 samples annually. In comparison, the unbiased workflows developed by leading proteomics labs can take weeks for sample preparation and MS measurement to reach an equivalent depth of proteomic coverage.
The Proteograph is increasingly being adopted by large-scale studies seeking an easy-to-use, scalable approach with a unique combination of attributes spanning breadth, depth, accuracy, reproducibility and precision of measurement. In 2025, we announced several collaborations to drive population-scale studies, including:
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Korea University: 20,000 subject proteomics biomarker discovery for early detection across multiple cancers
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Discovery Life Sciences: human cadaver multi-organ proteomic benchmarking study totaling over 10,000 samples for private company
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Performance relative to other plasma proteomics technologies. A 2024 head-to-head comparative study conducted by Dr. Joshua Coon, a professor at University of Wisconsin, and published in the Journal of Proteome Research demonstrates the performance of the Proteograph Product Suite utilizing the XT assay against five other plasma proteomic technologies and methods (Beimers et al.). Using five technical replicates of the same plasma sample (BioIVT) on each method, the study shows the Proteograph assay provides the greatest proteomic depth across the six technologies and methods tested. While providing much higher numbers of proteins, the Proteograph assay also provides the greatest reproducibility of all methods except neat. Against neat, the Proteograph has slightly worse reproducibility, but does so while quantifying almost eight-fold greater number of proteins including low abundance proteins.
Figure 14: (A) Across six technologies and methods tested, Proteograph XT provides the highest performance in protein identification across all replicates and within each replicate. (B) Demonstrates the reproducibility performance of each method by evaluating the median coefficient of variation (CV) values for proteins detected across all methods. A lower CV value indicates a higher degree of reproducibility.
The Advantages of the Proteograph Product Suite
We believe the Proteograph Product Suite and its underlying NP technology have unique advantages:
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Leading automated solution to enable unbiased, deep, rapid and large-scale access to the proteome. We pioneered the commercial development of unbiased sample enrichment for MS-based plasma proteomics. We believe we have become the trusted partner to our customers worldwide. While other solutions have been introduced since our commercial launch, we believe none can replicate the performance delivered by the Proteograph Product Suite, particularly the scale, depth, accuracy, and reproducibility to enable population-scale studies in an unbiased manner.
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Provides unique insight into protein variation at the peptide level, with a depth and scale that sets a new standard for unbiased and deep proteomics. By measuring >77,000 peptides per sample, the Proteograph has a differentiated ability to capture protein variations at scale to enable synergistic insights when combined with genomic variations, yielding informative individualized models of biology at population scale.
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Allows for wide adoption by customers in both decentralized and centralized settings. The Proteograph Product Suite is an integrated solution that includes consumables, an automation instrument and data analysis software, and was designed to deliver ease-of-use, efficiency, robustness and reproducibility of results and to complement existing laboratory infrastructure. Its simple and integrated workflow enables the customer to use their own MS instrument or leverage a widely available installed base of MS instruments, enabling broad adoption.
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Offers a core technology with the potential for development of a range of products, applications and platforms. Our diverse library of NP surfaces can support the development of new products catering to various applications and customer needs. We are using machine-learning techniques and conducting large-scale analyses to understand relationships between NP surfaces and protein binding to design future products.
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Provides core technology with significant operational leverage in research and development, manufacturing and commercialization. NP-based products are efficient to design, develop and manufacture. We believe that by leveraging our understanding of NP surfaces, software and analytics capabilities, we can rapidly develop new products. Our NP manufacturing process uses well-characterized inputs and methods, which require relatively modest investments in capital equipment and space. This capital-efficient and labor-efficient model has high operating leverage potential.
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Presents a solution with sustainable differentiation. The Proteograph is uniquely capable of generating robust, reproducible, deep and unbiased proteomic data. As this data is used by more customers to generate insights, we believe this cycle will fuel further adoption of the Proteograph Product Suite. The Proteograph workflow is fully integrable with customer workflows and provides a unique user experience with the support of our software packages, making it a sustainable solution within customer organizations. Our NP technology, automation instrument, and software are protected by numerous issued patents and pending patent applications worldwide, covering improvements in NPs, assay methods and ways to leverage proteomic data and information for life sciences research, clinical diagnostic and drug discovery applications.
The Applications of the Proteograph Product Suite
We believe the ability to generate unbiased, deep, proteomic data at scale, with rich content at the protein variant level, has a wide range of applications in proteomics, including basic research and discovery, translational research, diagnostics and applied markets. This data can be used in many of the same application areas as genomics data, as well as proteomics applications that are uniquely possible with unbiased proteomic data, and in new applications that the field will develop in the future.
In addition, the Proteograph Product Suite’s versatility allows it to analyze not only plasma and serum, but also other biofluids across humans and model organisms. For example, when we compared the performance of the Proteograph Product Suite workflow with that of neat biological samples across model organism plasma, cerebral spinal fluid, and conditioned media, we noted superior protein group identification by the Proteograph ONE workflow of 8x, 1.8x, and 6x, respectively. Importantly, in each sample, we measured tens of thousands of data points at the peptide-level, providing information on thousands of proteins. We believe this extensibility offers researchers a powerful and flexible tool to utilize across a variety of applications and sample types.
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Discovery Proteomics & Proteome Characterization. We believe the Proteograph is a valuable tool for basic research and discovery applications focused on comprehensive characterization of the proteome. The Proteograph enables researchers to explore protein diversity at peptide-level resolution, including the identification of protein variants and post-translational modifications such as glycosylation and phosphorylation.
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These capabilities support large-scale discovery efforts such as cataloging protein diversity, systems biology, interactome studies, and the integration of proteomic data with genomic and transcriptomic information. We anticipate that researchers will increasingly use Proteograph-generated data to build reference-scale maps of protein variation and function, providing biological context that is not readily accessible with other proteomics approaches.
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Translational & Biomarker Discovery Research. We believe the Proteograph Product Suite enables translational research applications aimed at accelerating the transition from discovery research to clinical relevance. The ability to perform deep, unbiased, and large-scale proteomics studies allows researchers to identify and prioritize protein biomarkers associated with disease risk, onset, progression, and heterogeneity.
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Diagnostic Development. As demonstrated with PrognomiQ, we believe the Proteograph has significant potential to support the development of diagnostic tests based on proteomic and multi-omic data. The generation of deep, unbiased, and scalable proteomic datasets has the potential to enable diagnostic ecosystems analogous to those that emerged with next-generation sequencing in genomics.
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Target Identification & Therapeutic Insight. We believe the Proteograph Product Suite may also be applied to therapeutic research, including target identification and exploration. Large-scale access to protein-level data linked to different states of health and disease can provide functional context for genomic discoveries and support the prioritization of potential therapeutic targets. Proteins identified through biomarker discovery or disease association studies may themselves represent therapeutic targets or may inform biological pathways and mechanisms relevant to drug development.
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Non-Human Research & Applied Applications. We see opportunities for the Proteograph Product Suite to be applied beyond human health research, including in animal health, model organism research, and industrial bioprocessing applications. The Proteograph workflow is compatible with multiple species, and we have observed customer adoption across a range of organisms, including mouse, non-human primate, canine, feline, avian, porcine, and bovine samples. In addition, we have seen increasing interest in the use of the Proteograph in bioprocessing applications, including host cell protein (HCP) analysis. In pilot studies, researchers combining the Proteograph workflow with liquid chromatography–mass spectrometry (LC-MS) identified 4 – 6x more HCPs for NIST monoclonal antibody compared to conventional LC-MS approaches, without additional sample preprocessing. We believe these applications demonstrate the versatility of the Proteograph Product Suite in addressing complex proteomic challenges across research, industrial, and applied settings.
Markets
We compete in the approximately $30 billion proteomics market, which is estimated by Frost & Sullivan to have spent approximately $17 billion on reagents and $13 billion on instruments in 2024.
We currently sell and market the Proteograph Product Suite for research use only (RUO). However, we believe that the capabilities of the Proteograph Product Suite may enable other applications in the future, including clinical and applied applications. Like the commercial impact of broadened access to genomics products, we believe the Proteograph will enable novel applications and insights, leading to new end-markets. For example, non-invasive prenatal testing and precision oncology currently make up a significant part of the current genomics market, which would have been difficult to predict a decade ago. We anticipate that the same dynamic of new market creation will occur in proteomics, with one such application for proteomics being early disease detection.
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Our Growth Strategy
Our mission is to imagine and pioneer new ways to decode the biology of the proteome to improve human health. Our growth strategy is to:
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Expand our addressable market through new product innovation. We aim to continuously innovate and develop new products, applications, workflows and analysis tools that create value across R&D from discovery to clinical research. Our proprietary NPs and core Proteograph platform provide us the ability and flexibility to rapidly innovate, develop new products, and address the needs of researchers and clinicians across the R&D value chain.
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Win additional population-scale cohort programs. In 2025, we announced several population-scale studies to power deep, unbiased proteomics leveraging the Proteograph. For the first time, scientists will be able to generate peptide-level proteomic data from large-scale cohorts, which we believe will unlock new biological insights and help usher in the next era of multi-omics driven precision medicine. We are also engaged in discussions with additional key biobanks to enable population-scale proteomic studies using the Proteograph.
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Grow and drive utilization of our rapidly expanding installed base. In 2025, we expanded our Proteograph installed base by more than 65% compared to 2024, with placements across academic, biopharma, and contract research organization customers. While we expect to continue growing our installed base, we are increasingly focused on driving higher utilization and consumable pull-through from existing customers. We plan to do so by working closely with customers to support their research objectives and by demonstrating the value of Proteograph-generated data, as reflected in a growing body of third-party scientific publications.
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Establish a leadership position as the preferred proteomic data platform for AI-driven biology. As biological research continues to shift from focused, hypothesis-driven studies toward large-scale, data-driven discovery, next-generation biological foundation models increasingly require high-quality, scalable, and differentiated datasets to generate novel insights. With highly differentiated, peptide-resolution proteomic data generated from the Proteograph, we believe our platform is well positioned to support AI-driven biological discovery and precision medicine. We intend to pursue strategic ecosystem partnerships to enable the generation of new biological insights from large, multimodal datasets.
Commercial
We continue to expand our third-party publications, enable unbiased and deep population-scale studies, and accelerate customer adoption of Proteograph. Our commercial strategy is focused on reducing friction for customers to access Proteograph data in support of their research. We continue to invest in and expand multiple access channels, including our direct sales organization, STAC services, centers of excellence service providers, international channel partners, and strategic commercial partnerships.
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Direct Sales: In North America, the United Kingdom, select countries of the European Union, and the Asia Pacific, we have direct sales and customer experience personnel, including Regional Business Managers (RBM), Field Application Scientists and Field Service Engineers. In addition to these direct personnel, we have marketing, customer experience and technical support personnel located in our offices in Redwood City and San Diego, California.
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Additionally, to reduce customer capital investment barriers, we launched the Strategic Instrument Placement Program (SIPP) in 2023 to enable customer access to our Proteograph without the need for an upfront capital investment. With an upfront purchase of consumable kits, we loan the instrument for a defined period of time with an option to purchase at the end of the loan term. This is allowing customers to utilize available operating budget without the need to access capital budget in the short term.
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Seer Technology Access Center (STAC): In June 2023, we announced the formation of the STAC to provide access to our Proteograph workflow, coupled with Thermo ScientificTMOrbitrapTM AstralTM MS, on a fee-for-service basis. The STAC’s primary purpose is to lower the barriers to access for customers who want access to data produced by these technologies. In May 2024, we announced the opening of our second STAC location in Bonn, Germany, in partnership with LIFE & BRAIN GmbH.
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Service Providers: We have partnered with eight select service facilities and core labs globally to be service providers for the Proteograph. These customers provide fee-for-service capabilities that allow third-party customers to access proteomic data from the Proteograph Product Suite using their own samples. We expect that these COEs will actively promote the Proteograph solution and its capabilities, help us further raise awareness, and increase the accessibility of the Proteograph to a wider range of customers.
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Channel Partners: We continue to expand geographically to enable access in key international markets, including China, Australia, Eastern Europe, Israel, Japan, and South Africa. These partners will help educate, develop and expand the market for the Proteograph Product Suite in their respective regions.
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Commercial Partnerships: In 2025, we operationalized a co-marketing and sales agreement with Thermo Fisher Scientific, which is expanding and accelerating access to the best-in-class deep, unbiased proteomic workflow to life science researchers worldwide and create a seamless sample-to-data experience for customers. Additionally, we are collaborating with Thermo Fisher Scientific on marketing activities and joint research and population-scale studies.
Suppliers and Manufacturing
Our overall manufacturing strategy is to continuously develop and refine our processes to achieve our objectives of continuity of supply, quality of supply and margin enhancement. Over time, this may lead to in-sourcing or outsourcing certain functions, including manufacturing, in various geographic locations in order to achieve our objectives.
Consumables
We leverage well-established unit operations to formulate and manufacture our NPs at our facilities in Redwood City, California. We procure certain components of our consumables from third-party manufacturers, which includes the commonly-available raw materials needed for manufacturing our proprietary engineered NPs. We are currently manufacturing using our production-scale lines and continue to build out our manufacturing capabilities to support the broad commercial availability of our products. We obtain some of the reagents and components used in the Proteograph workflow from third-party suppliers. While some of these reagents and components are currently sourced from a single supplier, these products are readily available from numerous suppliers. While we currently perform some filling and packaging of the Proteograph assay and the related consumables, we may eventually have our filling and packaging outsourced to a third party. We conduct vendor and component qualification for components provided by third-party suppliers and quality control tests on our NPs.
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Automation Instrument
We designed the SP200 automation instrument and have outsourced its manufacturing to Hamilton Company, a leading manufacturer of automated liquid handling workstations. We entered a non-exclusive agreement with Hamilton that covers the manufacturing of the SP200 automation instrument and its continued supply on a purchase order basis. In January 2025, we renewed the agreement under an extended term through December 2027. Following this extended term, the agreement will automatically renew annually for a maximum of two one-year renewal periods. Hamilton has represented to us that it maintains ISO 9001 and ISO 13485 certification.
Competition
The life sciences technology industry is highly dynamic, marked by rapidly advancing technologies, intense competition and a strong focus on intellectual property. In the proteomics market, companies offer a range of analytical instruments, such as chromatography and MS instruments, and associated reagents. Competition in the proteomics market is based on proprietary technologies, rapid product development capabilities, applications and intellectual property. We believe that no currently commercially available products offer the capability to conduct unbiased, deep proteomics studies of high dynamic range samples at the same scale and throughput as the Proteograph Product Suite. However, given the potential market opportunity and scientific promise of proteomics, we expect the competition to increase and, as a result, one or more competing products to emerge. Competing products may emerge from various sources, including life sciences tools, diagnostics, pharmaceutical and biotechnology companies, third-party service providers, academic research institutions, governmental agencies, and public and private research institutions.
Current companies that provide proteomics products include Agilent Technologies, Bio-Techne, Bruker, Danaher, DiaSorin, Illumina and Thermo Fisher Scientific. There are also a number of companies that provide proteomic analysis services. In addition, multiple emerging growth companies have developed, or are developing, proteomics products, services and solutions, such as Alamar Biosciences, Nautilus Biotechnology, Quanterix and Quantum-Si.
Government Regulation
The development, testing, manufacturing, marketing, post-market surveillance, distribution, advertising and labeling of certain of medical devices are subject to regulation in the United States by the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FDC Act) and comparable state and international agencies. FDA defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, which is (i) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (ii) intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Medical devices to be commercially distributed in the United States must receive from the FDA either clearance of a premarket notification, known as 510(k), or premarket approval pursuant to the FDC Act prior to marketing, unless subject to an exemption.
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We label and sell our products for RUO and expect to sell them to academic institutions, life sciences and research laboratories that conduct research, and biopharmaceutical and biotechnology companies for non-diagnostic and non-clinical purposes. Our products are not intended or promoted for use in clinical practice in the diagnosis of disease or other conditions, and they are labeled for research use only, not for use in diagnostic procedures. Accordingly, we believe our products, as we intend to market them, are not subject to regulation by FDA. Rather, while FDA regulations require that research use only products be labeled with – “For Research Use Only. Not for use in diagnostic procedures.” – the regulations do not subject such products to the FDA’s jurisdiction or the broader pre- and post-market controls for medical devices.
In November 2013, the FDA issued a final guidance on products labeled RUO, which, among other things, reaffirmed that a company may not make any clinical or diagnostic claims about an RUO product, stating that merely including a labeling statement that the product is for research purposes only will not necessarily render the device exempt from the FDA’s clearance, approval, or other regulatory requirements if the totality of circumstances surrounding the distribution of the product indicates that the manufacturer knows its product is being used by customers for diagnostic uses or the manufacturer intends such a use. These circumstances may include, among other things, written or verbal marketing claims regarding a product’s performance in clinical diagnostic applications and a manufacturer’s provision of technical support for such activities. If FDA were to determine, based on the totality of circumstances, that our products labeled and marketed for RUO are intended for diagnostic purposes, they would be considered medical devices that will require clearance or approval prior to commercialization. Further, sales of devices for diagnostic purposes may subject us to additional healthcare regulation. We continue to monitor the changing legal and regulatory landscape to ensure our compliance with any applicable rules, laws and regulations.
In the future, certain of our products or related applications could become subject to regulation as medical devices by the FDA. If we wish to label and expand product lines to address the diagnosis of disease, regulation by governmental authorities in the United States and other countries will become an increasingly significant factor in development, testing, production, and marketing. Products that we may develop in the molecular diagnostic markets, depending on their intended use, may be regulated as medical devices or in vitro diagnostic products (IVDs) by the FDA and comparable agencies in other countries. In the U.S., if we market our products for use in performing clinical diagnostics, such products would be subject to regulation by the FDA under pre-market and post-market control as medical devices, unless an exemption applies, we would be required to obtain either prior 510(k) clearance or prior premarket approval from the FDA before commercializing the product.
The FDA classifies medical devices into one of three classes. Devices deemed to pose lower risk to the patient are placed in either class I or II, which, unless an exemption applies, requires the manufacturer to submit a pre-market notification requesting FDA clearance for commercial distribution pursuant to Section 510(k) of the FDC Act. This process, known as 510(k) clearance, requires that the manufacturer demonstrate that the device is substantially equivalent to a previously cleared and legally marketed 510(k) device or a “pre-amendment” class III device for which pre-market approval applications (PMAs) have not been required by the FDA. This FDA review process typically takes from four to twelve months, although it can take longer. Most class I devices are exempted from this 510(k) premarket submission requirement. If no legally marketed predicate can be identified for a new device to enable the use of the 510(k) pathway, the device is automatically classified under the FDC Act as class III, which generally requires PMA approval. However, FDA can reclassify or use “de novo classification” for a device that meets the FDC Act standards for a class II device, permitting the device to be marketed without PMA approval. To grant such a reclassification, FDA must determine that the FDC Act’s general controls alone, or general controls and special controls together, are sufficient to provide a reasonable assurance of the device’s safety and effectiveness. The de novo classification route is generally less burdensome than the PMA approval process.
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Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices, or those deemed not substantially equivalent to a legally marketed predicate device, are placed in class III. Class III devices typically require PMA approval. To obtain PMA approval, an applicant must demonstrate the reasonable safety and effectiveness of the device based, in part, on data obtained in clinical studies. All clinical studies of investigational medical devices to determine safety and effectiveness must be conducted in accordance with FDA’s investigational device exemption (IDE) regulations, including the requirement for the study sponsor to submit an IDE application to FDA, unless exempt, which must become effective prior to commencing human clinical studies. PMA reviews generally last between one and two years, although they can take longer. Both the 510(k) and the PMA processes can be expensive and lengthy and may not result in clearance or approval. If we are required to submit our products for pre-market review by the FDA, we may be required to delay marketing and commercialization while we obtain premarket clearance or approval from the FDA. There would be no assurance that we could ever obtain such clearance or approval. In January 2024, FDA announced its plans to reclassify certain high-risk in vitro diagnostics, including companion diagnostics, as Class II devices.
All medical devices, including IVDs, that are regulated by the FDA are also subject to the Quality Management System Regulation (QMSR), which went into effect on February 2, 2026, replacing the former Quality System Regulation, and incorporates by reference the quality management system requirements of ISO 13485:2016. Obtaining the requisite regulatory approvals, including the FDA quality system inspections that are required for PMA approval, can be expensive and may involve considerable delay. The regulatory approval process for such products may be significantly delayed, may be significantly more expensive than anticipated, and may conclude without such products being approved by the FDA. Without timely regulatory approval, we will not be able to launch or successfully commercialize such diagnostic products. Changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time during the development or marketing of our products. This may negatively affect our ability to obtain or maintain FDA or comparable regulatory clearance or approval of our products in the future. In addition, regulatory agencies may introduce new requirements that may change the regulatory requirements for us or our customers, or both.
As noted above, although our products are currently labeled and sold for research purposes only, the regulatory requirements related to marketing, selling, and supporting such products could be uncertain and depend on the totality of circumstances. This uncertainty exists even if such use by our customers occurs without our consent. If the FDA or other regulatory authorities assert that any of our RUO products are subject to regulatory clearance or approval, our business, financial condition, or results of operations could be adversely affected.
For example, in some cases, our customers may use our RUO products in their own laboratory-developed tests (LDTs) or in other FDA-regulated products for clinical diagnostic use. The FDA has historically exercised enforcement discretion in not enforcing the medical device regulations against LDTs and LDT manufacturers. In May 2024, the FDA issued a final rule that phases out its enforcement discretion for most laboratory-developed tests (LDTs), which was vacated by the Texas district court in March 2025, clarifying that, while the FDA has jurisdiction to regulate diagnostic products, or tangible goods, the FDA does not have authority to regulate professional services performed by CLIA certified laboratories and regulated professionals. In June 2024, the U.S. Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous. This landmark Supreme Court decision may invite various stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA. Further, the changes under the current, including new leadership at the FDA, reduced staff, funding for certain programs, and new executive and Congressional actions may result in new policies and regulations that can impact the compliance status of our products or that of our customers.
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If our products become subject to FDA regulation as medical devices, we would need to invest significant time and resources to ensure ongoing compliance with FDA quality system regulations and other post-market regulatory requirements. It is unclear how future legislation by federal and state governments and FDA regulation will impact the industry, including our business and that of our customers. Any restrictions or heightened regulatory requirements on LDTs, IVDs, or RUO products by the FDA, HHS, Congress, or state regulatory authorities may decrease the demand for our products, increase our compliance costs, and negatively impact our business and profitability. We will continue to monitor and assess the impact of changing regulatory landscape on our business.
International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In the future, if we decide to distribute or market our diagnostic products as IVDs in Europe, such products will be subject to regulation under the IVD Medical Device Regulation (IVDR) European Union (EU) 2017/746, which replaced the IVD Directive, is significantly more extensive than the IVD Directive, including requirements on performance data and quality system, and went into application in May 2022. In 2025, the European Commission published its proposals on amendments to the IVDR as well as new transparency requirements. Outside of the EU, regulatory approval needs to be sought on a country-by-country basis in order to market medical devices. Although there is a trend towards harmonization of quality system, standards and regulations in each country may vary substantially which can affect timelines of introduction.
In the future, to the extent we or our partners develop any medical devices subject to FDA regulation, failure to comply with applicable regulatory requirements can result in enforcement action by FDA, which may include warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties; withdrawal, administrative detention, refunds, recall or seizure of products; operating restrictions, partial suspension or total shutdown of production; refusing or delaying requests for 510(k) clearance, de novo authorization, or PMA approval of new products or modified products; withdrawing 510(k) clearance, de novo authorization, or PMA approvals already granted; refusal to grant export approvals; or criminal prosecution. Further, manufacturing, sales, promotion and other activities following medical device clearance or approval are subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, including the CMS, other divisions of the Department of Health and Human Services, the Department of Justice, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and local governments. A medical device may be marketed only for the indications for use for which it was approved or cleared. In addition to FDA restrictions on marketing of devices, several other types of state and federal laws have been applied to restrict certain marketing practices in the device industry. These laws include the federal Anti-Kickback Statute, False Claims Act, Civil Monetary Penalties, and CMS Open Payments, among others.
In the future, if we or our partners develop any clinical diagnostic assays, we may pursue payment for such products through a diverse and broad range of channels and seek coverage and reimbursement by government health insurance programs and commercial third-party payors for such products. In the United States, there is no uniform coverage for clinical laboratory tests. The extent of coverage and rate of payment for covered services or items vary from payor to payor. Obtaining coverage and reimbursement for such products can be uncertain, time-consuming, and expensive, and, even if favorable coverage and reimbursement status were attained for our tests, to the extent applicable, less favorable coverage policies and reimbursement rates may be implemented in the future. Changes in healthcare regulatory policies could also increase our costs and subject us to additional regulatory requirements that may interrupt commercialization of our products, decrease our revenue and adversely impact sales of, and pricing of and reimbursement for, our products.
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The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their implementing regulations, which impose obligations, including mandatory contractual terms, with respect to safeguarding the transmission, security and privacy of protected health information by covered entities subject to HIPAA, such as health plans, health care clearinghouses and healthcare providers, and their respective business associates that access protected health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates in some cases, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
In addition, in the U.S., numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws, govern the collection, use, disclosure, and protection of health-related and other personal information. For example, in June 2018, the State of California enacted the CCPA, which came into effect on January 1, 2020 and provides new data privacy rights for consumers and new operational requirements for companies. While we are not currently subject to the CCPA, we may in the future be required to comply with the CCPA, which may increase our compliance costs and potential liability. Furthermore, the CCPA could mark the beginning of a trend toward more stringent state privacy legislation in the U.S., which could increase our potential liability and adversely affect our business.
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Furthermore, the collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in the European Economic Area (EEA), including personal health data, is subject to the GDPR, which became effective on May 25, 2018. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors. The GDPR also imposes strict rules on the transfer of personal data to countries outside the EEA, including the United States, and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines of up to €20 million or 4% of annual global revenues, whichever is greater. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. In addition, the GDPR includes restrictions on cross-border data transfers. The GDPR may increase our responsibility and liability in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, including as implemented by individual countries. Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities. Further, the United Kingdom’s decision to leave the EU, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom. As of January 1, 2021, and the expiry of transitional arrangements agreed to between the United Kingdom and EU, data processing in the United Kingdom is governed by a United Kingdom version of the GDPR (combining the GDPR and the Data Protection Act 2018), exposing us to two parallel regimes, each of which potentially authorizes similar fines and other potentially divergent enforcement actions for certain violations. Pursuant to the Trade and Cooperation Agreement, which went into effect on January 1, 2021, the United Kingdom and EU agreed to a specified period during which the United Kingdom will be treated like an EU member state in relation to processing and transfers of personal data for four months from January 1, 2021. This period may be extended by two further months. Furthermore, following the expiration of the specified period, there will be increasing scope for divergence in application, interpretation and enforcement of the data protection law as between the United Kingdom and EEA.
For further discussion of the risks we face relating to regulation, see the section titled “Risk factors—Risks related to our business and industry.”
Intellectual Property
Our success depends in part on our ability to obtain and maintain intellectual property protection for our products and technology. We use a variety of intellectual property protection strategies, including patents, trademarks, trade secrets and other methods of protecting proprietary information.
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As of December 31, 2025, we owned or exclusively licensed over 230 issued patents and patent applications worldwide. Our intellectual property portfolio includes patents and patent applications directed to proteomic assays, nanoparticle chemistry, data analysis and automation instruments. Our owned or exclusively licensed patents and patent applications, if issued, are expected to expire between 2023 and 2045, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
We exclusively license U.S. patents and patent applications, as well as ex-U.S. patents and pending patent applications from The Brigham and Women’s Hospital (BWH). These patents and patent applications are directed to methods for identifying a biological state, including classification and early detection of cancers and other diseases, using nanoparticle and biosensor compositions, as well as other nanoparticle compositions. Our in-licensed patents and patent applications, if issued, are expected to expire between 2034 and 2037, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
In addition to licensing patents and patent applications from BWH, we have also non-exclusively licensed certain of our patents and patent applications to PrognomiQ for use in the field of human diagnostics. Pursuant to our agreement with PrognomiQ, we also assigned a patent application related to lung cancer biomarkers to PrognomiQ. In connection with our agreement with PrognomiQ, we have granted PrognomiQ a non-exclusive sublicense to certain patents and patent applications that we license from BWH under our license agreement with BWH for use in the field of human diagnostics. For further information on the intellectual property transfer and license agreement with PrognomiQ and the license agreement with BWH, see the section titled “Business —Collaboration and License Agreements.”
We intend to pursue additional intellectual property protection to the extent we believe it would be beneficial and cost-effective. Our ability to stop third parties from making, using, selling, offering to sell, importing or otherwise commercializing any of our patented inventions, either directly or indirectly, will depend in part on our success in obtaining, defending and enforcing patent claims that cover our technology, inventions, and improvements. With respect to both our owned and in-licensed intellectual property, we cannot provide any assurance that any of our current or future patent applications will result in the issuance of patents in any particular jurisdiction, 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 commercializing infringing products or technology. Even if our pending patent applications are granted as issued patents, those patents may be challenged, circumvented or invalidated by third parties. Consequently, we may not obtain or maintain adequate patent protection for any of our products or technologies.
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In addition to our reliance on patent protection for our inventions, products and technologies, we also rely on trade secrets, know-how, confidentiality agreements and continuing technological innovation to develop and maintain our competitive position. For example, some elements of manufacturing processes, analytics techniques and processes, as well as computational-biological algorithms, and related processes and software, are based on unpatented trade secrets and know-how that are not publicly disclosed. Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees, advisors and consultants, these agreements may be breached or may be unenforceable and we may not have adequate remedies. In addition, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. As a result, we may not be able to meaningfully protect our trade secrets. For further discussion of the risks relating to intellectual property, see the section titled “Risk factors—Risks Related to our Intellectual Property.”
Collaboration and License Agreements
The Brigham and Women’s Hospital
In December 2017, we entered into an exclusive patent license agreement with BWH, pursuant to which we obtained an exclusive, royalty-bearing, sub-licensable (with approval from BWH) license to certain U.S. and foreign patents and patent applications in one patent family related to methods for identifying a biological state using nanoparticle and biosensor compositions and other nanoparticle compositions to develop, manufacture, use and commercialize products and processes in all fields, including but not limited to therapeutic, diagnostic, or other uses, on a worldwide basis. In addition, we were also granted an exclusive, royalty-bearing, sub-licensable (with approval from BWH) license to certain U.S. pending patent applications in another patent family to develop, manufacture, use and commercialize products and processes in all fields, including but not limited to therapeutic, diagnostic, or other uses, other than for the treatment of cancer through antigen-specific immune stimulation or the treatment of disease through immune tolerance or immune switching of lymphocyte subclasses. We may sublicense the patent rights licensed under the agreement subject to certain conditions, including obtaining the review and approval by BWH of such sublicense and any such sublicense must be consistent with and subject to the terms of the agreement.
In consideration for the licenses granted under the agreement, we must pay BWH annual license fees and a low single digit royalty on net sales of licensed products in any country during the term of the agreement, which is credited against the annual license fees. In the event we commercialize a product in the therapeutic space, we are also required to make certain drug-approval regulatory and commercialization milestone payments to BWH of up to a mid-seven digit figure in the aggregate for licensed products. In the event we sublicense any of the licensed intellectual property, we must pay BWH a percentage of any sublicense income received by us, which on a going-forward basis will be in the high single digits.
Under the terms of the agreement, we are required to use commercially reasonable efforts to develop and commercialize the licensed products, including in accordance to certain developmental, funding, regulatory and commercialization milestones. BWH controls the prosecution, maintenance and enforcement of all licensed patents and patent applications under the agreement.
Unless earlier terminated, the agreement continues until the expiration of the last to expire patent right licensed under the agreement. Subject to an applicable cure period, BWH may terminate the agreement if we fail to comply with applicable payments or diligence obligations or upon a breach of our obligation under the agreement, or for certain insolvency-related events.
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PrognomiQ
In August 2020, we entered into an intellectual property transfer and license agreement and, in October 2020, we entered into an intellectual property sublicense agreement, in each case with PrognomiQ in connection with the spin-out of PrognomiQ. Under the intellectual property transfer and license agreement, we granted PrognomiQ a non-exclusive, perpetual, irrevocable (subject to termination for breach) license to certain patents and patent applications that we own and, under the intellectual property sublicense agreement, we granted a non-exclusive sublicense to certain patent applications exclusively licensed from BWH, in each case, relating to our core technology to develop, manufacture and commercialize licensed products for the field of human diagnostics on a worldwide basis. In addition, we assigned a patent application relating to lung cancer biomarkers, and transferred certain clinical samples, contracts and other related assets to PrognomiQ. PrognomiQ may extend such licensed and sublicensed rights to customers of licensed products. PrognomiQ is not required to pay us any royalties or fees pursuant to the intellectual property transfer and license agreement. In consideration of the non-exclusive sublicense to certain patent applications licensed from BWH, PrognomiQ paid us a low-five digit figure, and would pay a low single digit royalty, in an amount equivalent to what we would have to pay under our license with BWH, on net sales of sublicensed products beginning with the first commercial sale of a sublicensed product during the term of the intellectual property sublicense agreement.
In the event we elect to grant an exclusive license to a third party in the field of human diagnostics for any of the patents and patent applications licensed or sublicensed, as applicable, to PrognomiQ under the respective agreements, we are required to first negotiate with PrognomiQ for a period of sixty days for a license or sublicense, as applicable, to such rights on reasonable terms. Furthermore, for a period of two years after the effective date, we are required to negotiate in good faith with PrognomiQ for a license or sublicense, as applicable, to any improvements to the patents and patent applications assigned or licensed or sublicensed, as applicable, under the intellectual property transfer and license agreement and the intellectual property sublicense agreement.
Neither party may assign the intellectual property transfer and license agreement nor any rights or obligations under the agreement without the other party’s prior written consent, other than to an affiliate or pursuant to an acquisition. PrognomiQ may not assign the intellectual property sublicense agreement or any rights or obligations under the agreement without our prior written consent, other than to an affiliate or pursuant to an acquisition, and in any event only with BWH’s prior written consent. Our right to assign the intellectual property sublicense agreement and any rights or obligations under the agreement is subject to the terms and conditions of our license with BWH. Unless terminated earlier, the terms of both agreements continue until the expiration of the last to expire intellectual property right granted under such agreement. Either party may terminate either agreement for an uncured breach of the other party, upon which all licenses granted under such agreement to the breaching party will terminate.
Scientific Advisory Board
We have assembled a highly-qualified scientific advisory board composed of advisors who have deep expertise in the fields of nanotechnology, proteomics, genomics, medicine, regulatory compliance and data science. Our scientific advisory board is composed of Robert Langer, Sc.D., Charles Cantor, Ph.D., Joshua Coon, Ph.D., Luis Diaz, M.D., Vivek Farias, Ph.D., Chris Mason, Ph.D., Mark McClellan, Ph.D., Gary Patti, Ph.D., Jennifer Van Eyk, Ph.D., M.D., and Bruce Wilcox, Ph.D.
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Employees
Our employees are guided by our mission to imagine and pioneer news ways to decode the biology of the proteome to improve human health. Our core values Better Together, Customer Centric, Difference Makers, People First and Trailblazers guide us toward achieving our mission. Our core values set the foundation for how we conduct business, interact with each other and our customers and evaluate employee performance.
As of December 31, 2025, we had 124 employees based in North America, the European Union and the United Kingdom. Many of our employees are highly educated, holding masters and doctorate degrees. None of our employees is represented by a labor union or covered under a collective bargaining agreement.
Our human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants. The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through the granting of stock-based and cash-based compensation awards to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.
Corporate Information and History
We were incorporated in Delaware on March 16, 2017, under the name Seer Biosciences, Inc., and changed our name to Seer, Inc. on July 16, 2018. Our principal executive offices are located at 3800 Bridge Parkway, Suite 102, Redwood City, California 94065. Our telephone number is 650-543-0000. Our website address is http://seer.bio. Information contained on, or that can be accessed through, our website should not be considered to be part of this Annual Report.
We use Seer and Proteograph as trademarks in the United States and other countries. This Annual Report contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Annual Report, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity.
References
Published studies referenced throughout this Annual Report are cited below. These studies are not a part of this prospectus and are not incorporated by reference in this Annual Report.
Backman, J.D. et al. Exome sequencing and analysis of 454,787 UK Biobank participants. Nature 599, 628–634 (2021).
Beimers W, Overmyer K, et al. Technical Evaluation of Plasma Proteomics Technologies. J. Proteome Res. 2025, 24, 6, 3074–3087.
Bludau, I. et al. Proteomic and interactomic insights into the molecular basis of cell functional diversity. Nat Rev Molec Cell Biol21, 327–340 (2020).
Blume, J.E. et al. Rapid, deep and precise profiling of the plasma proteome with multi-nanoparticle protein corona. Nat. Commun. 11 (2020).
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Ferdosi, S. et al. Engineered nanoparticles enable deep proteomic studies at scale by leveraging tunable nano-bio interactions. PNAS. 119(11) (2022).
Ferdosi, S. et al. Enhanced competition at the nano-bio interface enables comprehensive characterization of protein corona dynamics and deep coverage of proteomes. Advanced Materials. 34, 2206008 (2022).
Olinger, B., Banarjee, R., Dey, A. et al. The secretome of senescent monocytes predicts age-related clinical outcomes in humans. Nat Aging 5, 1266–1279 (2025).
Pietzner, M. et al. Synergistic insights into human health from aptamer- and antibody-based proteomic profiling. Nat Commun. 12, 6822 (2021).
M Pietzner, A. Williamson et. al. Nanoparticle enriched mass spectrometry proteomics in British South Asians identifies novel variant-protein-disease mechanisms. (bioRxiv).
Suhre, K. et al. Nanoparticle enrichment mass-spectrometry proteomics identifies protein-altering variants for precise pQTL mapping. Nat Commun, 15, 989 (2024).
Suhre, K., Chen, Q., Halama, A. et al. A genome-wide association study of mass spectrometry proteomics using a nanoparticle enrichment platform. Nat Genet 57, 2987–2996 (2025).
Yang X. et al. Widespread Expansion of Protein Interaction Capabilities by Alternative Splicing. Cell. 164(4):805-17 (2016).
Available Information
We make our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports, available free of charge at our website as soon as reasonably practicable after they have been filed with the SEC. Our website address is http://seer.bio. Information on our website is not part of this report. The SEC maintains a website that contains the materials we file with the SEC at www.sec.gov.
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