Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 15

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 15
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 the single DNA molecule. This leap forward addresses a fundamental limitation in healthcare – the inability to detect sparse but clinically crucial disease signals in cfDNA. Our superior technology platform 1has enabled us to build category-defining prenatal and oncology products. Our products reveal actionable insights from a simple blood draw that are fundamentally changing how diseases are diagnosed and treated, leading to a paradigm shift in personalized medicine. 2We believe our novel smNGS platform technologies combined 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. 3 Founded with the mission to remove the fear of the unknown through powerful and accessible smNGS-based diagnostics, we have swiftly transitioned from a research and development (R&D) focused company 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 (SCD) and cystic fibrosis (CF) 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. While 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. 4 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

| 1 |     | Our smNGS platform overcomes the technical noise that restrains the traditional NGS testing methods used by other diagnostic companies. Please see “Business—Our Technology” for more details. |

| 2 |     | For further information on the impact of our products on how diseases are diagnosed and treated, please see “Business—Patient Case Studies”. |

| 3 |     | Half of this addressable market