Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 173

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 173
---
 increasing focus on molecular-targeted cancer treatments. However, current imaging and conventional liquid biopsy approaches present critical shortcomings, including missed actionable mutations and delays in detecting treatment response and progression.

| 33 |     | 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.                                                                                                                                                                                                    |

| 34 |     | 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.                                                                                                                            |

124

In 2023, we entered the oncology market with two complementary products that leverage our smNGS platform to address these unmet needs. Northstar Select, our ultrasensitive liquid biopsy test, provides insights into appropriate therapies for stage III or IV cancer patients. In a head-to-headstudy presented at American Society of Clinical Oncology (ASCO) annual meeting in 2024, our test demonstrated superior performance by detecting 51% more pathogenic and actionable SNVs and 109% more CNVs than conventional liquid biopsies 35. Northstar Select targets the therapy selection cancer diagnostics market, which we estimate is an annual United States market opportunity of over $6 billion. 34 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. 34 The clinical value of our oncology portfolio is validated by physician adoption. More than 95% of oncologists who order our tests utilize both Northstar Select and Northstar Response in tandem, highlighting their complementarity in guiding cancer care. Additional opportunities in oncology We are actively developing additional diagnostic products to address critical needs across the cancer care continuum. Our current development efforts focus on MRD detection, leveraging our platform’s exceptional sensitivity to identify trace amounts of tumor DNA following curative-intent surgery in earlier stage cancers. We are developing a