Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 209

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 209
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 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-invasive prenatal 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-invasive
prenatal 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

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villus sampling. 53Prior 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 screening due to barriers related to cost, availability, and willingness. 54As a result, at least 58% of pregnancies affected by these conditions are undetected. Our smNGS-based tests offer the level of precision and quantification necessary to overcome these challenges and provide a solution to this problem. Our UNITY Complete portfolio Our UNITY prenatal testing portfolio includes the first sgNIPT that uses cfDNA to achieve precise fetal risk analysis without requiring a paternal sample – a breakthrough that enhances accessibility, ease of use, and adoption across patient populations. In 2020, we added Aneuploidy and RhD NIPT to create our UNITY Complete offering. In 2022, we added other fetal red blood cell antigens for alloimmunized pregnancies at risk for HDFN without requiring a paternal sample or invasive procedures such as amniocentesis. Our portfolio delivers unmatched clinical insights through the screening for recessive conditions, aneuploidies, and fetal antigens using a single maternal blood draw. We believe our offering provides the most comprehensive view of fetal health available today.

| 53 |     | Hsieh, V., Sherer, D. M., Davydovych, K., Kheyman