Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 24

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 24
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 See “Risk Factors—Risks related to legal and regulatory matters—Our tests are currently marketed as LDTs, and future changes in FDA enforcement of LDTs could subject our operations                   
 to much more significant regulatory requirements.” See also “Business—Government regulations—New York laboratory licensing.”                                                                                                                            |

| 15 |     | While we have not yet started development in this area, the research work for MRD and our Select and Response tests is a necessary precusor to early detection development. We also believe that there is significant                           
 potential for our smNGS platform to accommodate products in this area. We believe the molecular information provided by our tests can assist in predicting the diagnostic pathway that can confirm the presence and tissue of origin of cancer. |

| 16 |     | 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.                                                                                                                                                                                                    |

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addition, it reports fetal aneuploidy and 22q11.2 microdeletion, enabling complete genetic insights from a single maternal blood draw. We estimate the prenatal market represents an annual opportunity of over $2.5 billion in the United States. 17 Oncology products ONCOLOGY Select: Cancer treatment selection Response: Cancer treatment response monitoring Minimum Residual Disease (MRD): Cancer detection & surveillance post-surgery In Development Non-invasiveliquid biopsy tests are a rapidly growing approach to detect and measure tumor DNA, driven by the 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. 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 the 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. 18Northstar Select targets the therapy selection cancer diagnostics market, which we estimate is an annual United States market opportunity of over $6 billion. 19 We simultaneously launched Northstar Response,