Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 193

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 193
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 continue to generate unique data via our smNGS platform, we are building a differentiated and clinically actionable genomics dataset. Our advantage stems from two key factors: first, our biomarker measurements achieve single-molecule precision and sensitivity, capturing the key disease-causing molecular signatures in cfDNA; and second, our response monitoring assay provides an objective measurement of how a patient is responding to a therapy. AI has recently unlocked widespread access to and analysis of multimodal patient clinical history data. This powerful combination positions us to harness AI for identifying distinct patient subgroups based on their specific biomarker profiles and for predicting how each subgroup will respond to different therapeutic approaches. By mapping these response patterns with extraordinary granularity, we believe we will be able to deliver personalized treatment recommendations based on each person’s unique biology that maximize efficacy while minimizing adverse effects — moving precision medicine from aspiration to clinical reality. While our AI-enabledvision represents the future of our platform, our commercial success today demonstrates the fundamental value of our existing products. Our existing products in prenatal and oncology have already demonstrated strong growth from zero to $266.3 million annualized revenue run-rate(ARR) in five years as of June 30, 2025. As we expand into new and larger markets, we believe that our foundational smNGS platform will position us to become a generational healthcare company.

| 43 |     | Both MRD and early-detection assays are designed to detect minute amounts of cancer DNA in blood (e.g., at levels of 0.01% or even lower). Given the trade off between specificity and sensitivity (LOD), this higher                             
 specificity can be, in principle, achieved by changing the calling threshold. As a part of our five-year strategic plan, we have included the necessary R&D funding for development of an early detection test that builds upon our earlier work. |

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Our Technology The BillionToOne smNGS platform leverages proprietary and patent-protected technologies that allow us to detect previously undetectable diseases and support physicians developing and managing treatment plans for patients. Our platform integrates our patented QCTs, proprietary machine learning algorithms embedded in sophisticated bioinformatics systems, and a quantitative, iterative, engineering-oriented assay design. These complementary technologies achieve single-molecule precision with large scale multiplex capabilities, bypassing the tradeoff between precision and scale that limits traditional NGS methods. We developed our smNGS platform specifically to address the fundamental challenge of cfDNA scarcity. cfDNA is the extracellular DNA found in blood plasma that is released by all tissues as a