Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 22

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 22
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 and potentially for early cancer detection. We are in the late stages of development of our first assay for MRD detection, and we anticipate launching this assay in 2026. We expect that any products we launch for MRD will be laboratory developed tests (LDTs), and the products would not be subject to FDA approval requirements. 14Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection; however, we have not yet started development in this area. 15 To date, we have launched multiple products across these large addressable markets. We performed approximately 508,000 smNGS-based tests in the last 12 months ended June 30, 2025, with significant room to further grow test volume in both markets. Prenatal products PRENATAL Fetal Risk Screen: Inherited conditions Aneuploidy Screen: Chromosomal + microdeletion conditions Fetal RhD + Fetal Antigen NIPT: Non-alloimmunized and alloimmunized pregnancies Traditional prenatal screening focuses on assessing a fetus’ risk for larger chromosomal changes. However, many common and severe conditions are the result of much smaller genetic changes, in single base pairs. These recessively inherited conditions, including SCD, alpha thalassemia, beta-thalassemia, CF, and SMA, are collectively more common than aneuploidy conditions like Down syndrome. Yet these conditions cannot be directly tested with traditional NIPT since each condition requires the precise quantification of fetal cfDNA. Given the technical challenges of directly assessing the fetal risk for these conditions, current medical guidelines recommend that every pregnant patient is offered carrier screening, with father screening then required if the mother is found to be a carrier. However, studies estimate that fewer than half of fathers complete the recommended screening due to barriers related to cost, availability, and willingness. As a result, approximately 58% of pregnancies affected by these recessive conditions are undetected by traditional screening workflows. 16 Our UNITY Complete Fetal Risk Screen directly addressed these challenges and is the first test that uses cfDNA to provide precise fetal risk assessments for recessive conditions without requiring a paternal sample. In

| 14 |     | Each of our genetic tests is a LDT. The FDA has historically taken the position that it has the authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act, but it has generally                                       
 exercised enforcement discretion with regard to such