Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 199

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 199
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 global fight to cure cancer. However, despite significant advancements and growth in the field, cancer continues to rank as the second leading cause of death worldwide, 55with persistently high mortality rates. Liquid biopsies, or blood-based tests that interrogate ctDNA, cfDNA released from a tumor cell, for therapy selection or disease monitoring have recently become available for clinical practice as non-invasive,rapid and readily available alternatives to traditional tissue-based biopsies. Despite the increase in uptake, current liquid biopsies developed using standard NGS methods present shortcomings, including undetected actionable mutations and delays in detection of response and progression. In a head-to-headstudy presented at ASCO in 2024, we have shown that more than one-thirdof actionable mutations are undetected by other liquid biopsies due to lower sensitivities at lower variant allele fractions. Moreover, current products are also limited in their ability to quickly, precisely, and sensitively quantify trends in tumor progression over the course of treatment. Our Northstar portfolio Our Northstar portfolio for oncology consists of smNGS-based pan-cancerliquid biopsy tests that provide comprehensive therapy selection (Northstar Select) and therapy monitoring (Northstar Response) for late-stage, solid tumor cancer patients. Using a blood-only approach with a focus on sensitivity and precision, we are committed to pushing the limits of cfDNA testing to ensure patients are getting the most advanced profiling and monitoring tools available, while maintaining the convenience of a single blood draw. Northstar Select In January 2023, we launched Northstar Select, which is an ultrasensitive liquid biopsy test using smNGS. Northstar Select can provide insight into what therapies may be appropriate for a patient with stage III or IV cancer. Our Northstar Select test has demonstrated industry-leading performance, including two to five times lower LOD, which results in more than 50% more actionable mutations identified than comparator products. 56

| 55 |     | GBD 2021 Cancer Collaboration. Global burden of cancer and associated risk factors in 204 countries and territories, 1980-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Oncol. |

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In 2025, the MolDX Program, which is administered by Palmetto GBA, a Medicare administrative contractor, determined Northstar Select meets the coverage requirements under LCD L38043. The MolDX Program’s thorough review process confirms Northstar Select’s clinical validity and utility and enables reimbursement for Medicare and