Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 223

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 223
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 improvements to the Northstar Response assay designed to achieve superior clinical performance than existing assays using the tumor-naive (blood only) approach. We believe there is a significant market opportunity for tumor-naive MRD assays, especially in certain cancer types such as lung, where the QC failure rates for tissue testing can exceed 40%. 66Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection. We have leveraged our existing relationship with Allegheny Health Network to collaborate on procuring a retrospective sample set to begin assessment of our MRD assay across multiple tumor types including CRC and endometrial cancers. Publications and collaborations We have extensive publications on our smNGS platform and products. Our UNITY Fetal Risk Screen clinical publication in Genetics in Medicine was selected for the Top 10 publications in Genomic medicine year in review 2023 by AJHG. Our hallmark publications in the Obstetrics & Gynecology journal (the Green Journal) demonstrated 100% sensitivity and specificity in approximately 860 patients for fetal RhD and other fetal RBC antigen detection, ultimately leading to the ACOG practice guideline changes. The analytical and clinical validity of our Northstar products have also been demonstrated in peer-reviewed publications. The analytical validation of Northstar Response was published in January 2025 in Scientific Reports while additional clinical studies of the assay performance in lung and liver cancer cohorts were published in Clinical Lung Cancerand the Journal of American College of Surgeons,respectively. The analytical and clinical validation of Northstar Select, including the head-to-headcomparison against other on-marketassays published in August 2025 which demonstrated Northstar Selects superiority in detection of SNV and CNVs as relative to commercially available competitors. 67Beyond the peer-reviewed journal publications below, we have published posters and abstracts at various medical conferences including AACR, AACR LBx, ASCO, and the International Society of Liquid Biopsy.

| 66 |     | Choudhury, Y., Tan, M.-H., Shi, J. L., Tee, A., Ngeow, K. C., Poh, J., Goh, R. R., & Mong, J. (2022). Complementing tissue testing with plasma mutation profiling improves therapeutic decision-making for patients 
 with lung cancer. Frontiers in Medicine, 9, 758464.                                                                                                                                                                 |

| 67 |     | Bower, X., Wignall, J., Varga, M. G