Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 190

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 190
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 but exercised enforcement                                 
 discretion until it recently rescinded LDT regulations indicating that it does not have the authority to require clearance, de novo classification, or approval of LDTs prior to market release. As a result, our molecular diagnostic products are not 
 currently subject to FDA approval requirements. While LDT tests do not require FDA approval currently, they are subject to state regulatory requirements, such as under New York States CLEP, which reviewed LDTs for accuracy. 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.”                                                                                                                                                                                        |

| 37 |     | While we have not yet started development in this area, the research work for MRD and our Select and Response tests is a necessary precursor 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. |

| 39 |     | 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.                                                                                                                                                                                                    |

| 40 |     | 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.                                                                                                                |

133

Oncology products ONCOLOGY Select: Cancer treatment selection NORTHSTAR 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