Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 226

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 226
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 549 SNVs/Indels 22 109% more CNVs 46 CNVs Comparators NORTHSTAR SELECT Comparators NORTHSTAR SELECT Variants detected at VAF below 0.20% were overwhelmingly detected by Northstar Select(R) only % VAF % Variant Allele Fraction (VAF) 100 10 1 0.1 0.01 0.001 Detected by Both Northstar Select and Comparators Detected by Comparators Only Comparators 12345 0.5% VAF 0.2% VAF Detected by Northstar Select Only Northstar Response In January 2023, we launched Northstar Response, a pan-cancersmNGS-based liquid biopsy test that precisely measured more than 500 genomic loci uniquely methylated in cancer, achieving single-molecule level quantification, without the need for an upfront tissue-sample. 69In May 2025, along with other improvements, we updated the assay to include more than 2,200 genomic loci. The new version of the assay has a significantly lower LOD, achieving 0.01% LOD. Northstar Response provides epigenomic insight into dynamic changes in a patient’s response to therapy and, based on our knowledge of all widely available tests, is the only tissue-free methylation-based assay that quantifies tumor burden with single molecule precision. We believe Northstar Response offers a convenient and more precise method to accurately monitor the molecular changes occurring during a patient’s treatment course, which can enable real-time treatment decisions for physicians and patients. Northstar Response is complementary to standard of care radiographic imaging The ability to monitor a tumor’s response to therapy and rapidly adjust treatment strategy when necessary is pivotal to improving patient outcomes, especially in late-stage cancers. Today, the most common and accepted method to assess treatment response is by measuring changes in tumor size through radiographic imaging

| 67 |     | The percentages are calculated for actionable/reportable mutations when compared to the comparator products in the aggregate. Actual percentages may vary depending on the individual comparator test. |

| 68 |     | Bower, X., Wignall, J., Varga, M. G., Zhu, J., O’Sullivan, M., Searle, N. E., Hong, L. K., Dogruluk, T., Li, Z., Farmer, T. E., Rosas-Linhard, E., Luong, J., Lin, E., Simon, M. E., Tsao, D. S