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

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 25
---
 performance by detecting 51% more pathogenic and actionable SNVs and 109% more CNVs than conventional liquid biopsies. 19Northstar Select targets the therapy selection cancer diagnostics market, which we estimate is an annual United States market opportunity of over $6 billion. 20 We simultaneously launched Northstar Response, the only tissue-free, pan-cancer,smNGS-based liquid biopsy test that precisely measures thousands of genomic loci uniquely methylated in cancer to provide insight into dynamic changes in therapy response. Validation studies showed Northstar Response’s consistent ability to detect changes in tumor fraction across more than 10 different cancer types, in some cases as much as six months earlier than indicated by imaging scans. Northstar Response targets the cancer therapy response diagnostics market, which we estimate is an annual United States market opportunity of over $15 billion. 20

| 17 |     | Riku, S., Herman, M., et al. (2022). Reflex single-gene non-invasive prenatal testing is associated with markedly better detection of fetuses affected with single-gene recessive disorders at lower cost. Journal of 
 Medical Economics.                                                                                                                                                                                                    |

| 18 |     | See “Management’s discussion and analysis of financial condition and results of operations—Key factors affecting our results of operations and performance” for more information regarding how 
 these total addressable markets are calculated, including material assumptions.                                                                                                                |

| 19 |     | 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., Bosch, J. R. T., 
 Palmer, G., Gajra, A., Huynh, C., & Zhou, W. (2025). Validation of a liquid biopsy assay with increased sensitivity for clinical comprehensive genomic profiling. The Journal of Liquid Biopsy, 100322.            |

| 20 |     | See “Management’s discussion and analysis of financial condition and results of operations—Key factors affecting our results of operations and performance” for more information regarding how 
 these total addressable markets are calculated, including material assumptions.                                                                                                                |

8

The clinical value of our oncology portfolio is validated by physician adoption. More