Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 180

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 180
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 with our AI-enhancedintegrated workflow, allows us to push the technology frontier forward and deliver on the full promise of non-invasiveliquid biopsy, which we estimate has an annual market opportunity of over $100 billion in the United States alone. Half of this addressable market includes early detection, an area in which we have not yet begun specific product development or commercial sales, but we believe will be strongly enabled by our existing technology platform. Founded with the mission to remove the fear of the unknown through powerful and accessible smNGS-based diagnostics, we have swiftly transitioned from an R&D-focusedcompany to a proven commercial organization. In 2019, we launched our first prenatal product, UNITY. UNITY is the first non-invasiveprenatal test (NIPT) that uses cfDNA to provide fetal risk assessment for recessive conditions such as sickle cell disease and cystic fibrosis without requiring a paternal sample or invasive procedures such as amniocentesis. Since then, we have established ourselves as a leader in the prenatal testing market and expanded our UNITY offering to cover comprehensive prenatal genetic needs from a single maternal blood draw. 28While we know of competitors working to develop and launch competing NIPTs for recessive conditions, we believe the differentiation of our smNGS technology and five years of accumulated data and publications will allow us to maintain our competitive advantage as this type of testing becomes the standard of care and significantly improves patient outcomes. In the oncology setting, ultrasensitive tests with real-time insights are required to effectively detect, diagnose, and treat patients with a diverse range of mutations and solid tumor types across the cancer care continuum. In 2023, we successfully leveraged our smNGS platform to launch two complementary pan-cancerliquid biopsy tests – Northstar Select and Northstar Response. Our Northstar Select test is used to guide therapy selection and has been shown to detect over 50% more actionable solid tumor mutations than conventional liquid biopsies. 29Based on our knowledge of all widely available tests, Northstar Response is the only methylation-based assay that quantifies the amount of cancer (tumor burden) at the single molecule level without requiring a tissue biopsy, enabling real-time monitoring of patient response to therapy with unprecedented precision. Our Northstar tests give physicians extraordinary visibility into cancer profile and treatment response, enabling more informed and earlier treatment decisions that can fundamentally alter patient outcomes. Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. Of approximately one million smNGS-based tests that