Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 215

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 215
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 to further grow test volume in both markets. PRENATAL ij UNITY 2019 2020 2021 << Fetal Risk Screen The only commercial single-gene NIPT in US for recessive conditions Aneuploidy NIPT + RhD NIPT NIPT for T21, 18, 13, and sex aneuploidies with opt-in RhD NIPT << Fetal Antigen NIPT The only commercial red blood cell NIPT in US for D, Kell, C/C, E, and Duffy ONCOLOGY NORTHSTAR 2023 2023 Future << Select 84-gene treatment selection panel with 2-5x lower LOD " Response The only treatment response monitoring test that precisely quantifies methylation " Minimum Residual Disease (MRD): Cancer detection & surveillance post-surgery Tumor-naive MRD assay with unprecedented LOD Prenatal products Traditional non-invasiveprenatal screening focuses on assessing a fetus’ risk for larger chromosomal changes, such as Down syndrome. However, several common and severe conditions are the result of much smaller genetic changes. Identifying these tiny changes within cfDNA is technically challenging and requires precise quantification to separate the contribution of relatively sparse fetal signal from the significant maternal background DNA, especially for recessive conditions such as SCD, alpha thalassemia, beta-thalassemia, CF, and SMA. Since traditional non-invasiveprenatal tests (NIPTs) are unable to screen for these recessively-inherited, single-gene conditions, diagnosing these disorders in the fetus requires invasive methods such as amniocentesis or chorionic villus sampling. 56Prior to such invasive testing, conventional carrier screening has to be completed and requires a paternal sample. Third party studies estimate that fewer than half of the fathers complete the recommended

| 56 |     | Hsieh, V., Sherer, D. M., Davydovych, K., Kheyman, M., & Dalloul, M. (2025). The art (and science) of Individualized Selection of Non-Invasive Prenatal Screening (NIPS). International Journal of Women S Health, 
 Volume 17, 1271–1283,                                                                                                                                                                                              |

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screening due to barriers related to cost, availability, and willingness. 57As a result, at least 58% of pregnancies affected by these conditions are undetected. Our smNGS-based tests offer the level of precision