Company: BLLN
Filing Date: 2025-10-17
Form Type: S-1/A
Source: 0001193125-25-242632
Chunk: 149

Company: BillionToOne, Inc.
Filing Date: 2025-10-17
Form: S-1/A
Chunk 149
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 codes that may not fully capture the uniqueness and value that our tests provide. These codes facilitate appropriate billing and reimbursement from 
 payors and drive broader clinical adoption. For instance, our UNITY Carrier Screen was assigned a PLA code, 0449U, which has received CMS pricing of $1,825, effective January 1, 2025. Similarly, our Northstar Select and Northstar Response      
 products received PLA codes 0487U and 0486U, respectively, with CMS pricing of $2,920 and $1,644 respectively. As our codes of 0449U and 0487U have been added to the coverage policies of payors, including Medicare for the latter, our ASPs have 
 increased.                                                                                                                                                                                                                                          |

| • |     | Expanding payor coverage criteria and clinical utility: Changes in payor policies, such as the expansion of 
 coverage criteria or the recognition of new indications, can have a pronounced effect on                    |

| 27 |     | 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.                                                                                                                                                                                                    |

98

| our revenues and ASPs. In 2024, several payors began covering additional tests within our prenatal panel, specifically those for 22q11.2 deletion syndrome (22q microdeletion), RhD NIPT, and fetal                                                   
 antigen NIPT. Most recently, Geisinger issued a positive coverage policy for the sgNIPT component of our Fetal Risk Screen for recessive conditions. The inclusion of these tests in positive coverage policies has directly contributed to a notable 
 improvement in the Overall ASP for our prenatal product portfolio.                                                                                                                                                                                    |

Moreover, we achieved a significant milestone earlier this year with the receipt of a positive coverage determination from Medicare’s MolDX for Northstar Select. As a result, Medicare coverage for Northstar Select began on February 14, 2025, expanding access for eligible patients. We plan to submit additional dossiers to MolDX for further coverage evaluations for Northstar Response, which, if successful, would significantly increase our ASPs in the future. Our continued engagement with medical societies and generation of clinical utility evidence may also facilitate the inclusion of our tests in future clinical practice guidelines. For instance, even with more recent expansions, 22q11.2 microdeletion that we provide is only reimb