Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 92

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 92
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 of regulations may, directly or indirectly, reduce our revenue, adversely affect our results of operations and financial condition, and harm our business. The molecular diagnostics industry is highly regulated, and there can be no assurance that the regulatory environment in which we operate will not change significantly and adversely to us in the future. Areas of the regulatory environment that may affect our ability to conduct business include, without limitation:

| • |     | federal, state and foreign laws applicable to test ordering, documentation of tests ordered, billing practices and claims 
 payment and/or regulatory agencies enforcing those laws and regulations;                                                  |

| • |     | federal, state and foreign health care fraud and abuse laws; |

| • |     | federal, state and foreign laboratory anti-mark-up laws; |

| • |     | coverage and reimbursement levels by Medicare, Medicaid, other governmental payors and private insurers; |

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| • |     | restrictions on coverage of and reimbursement for tests; |

| • |     | federal, state and foreign laws governing laboratory testing, including CLIA, and state licensing laws; |

| • |     | federal, state and foreign laws and enforcement policies governing the development, use and distribution of diagnostic 
 medical devices;                                                                                                       |

| • |     | laws and regulations governing the marketing of molecular diagnostic tests, including by the FDA pursuant to the medical 
 device provisions of the Federal Food, Drug and Cosmetic Act or FDCA;                                                    |

| • |     | FDA regulation, via the FDCA and its implementing regulations, of the research, design, testing, manufacturing, safety,                                        
 labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion and sales and distribution of medical devices in the United States; |

| • |     | FDA regulation of the import and export of medical devices; |

| • |     | federal and state laws and enforcement policies governing the use of AI in analyzing data, including data in 
 healthcare-related areas;                                                                                    |

| • |     | federal, state, local and foreign laws governing the handling and disposal of medical and hazardous waste; |

| • |     | federal and state Occupational Safety and Health Administration rules and regulations; |

| • |     | HIPAA, GDPR, CCPA, CPRA and similar state or foreign data privacy and security laws; and |

| • |     | consumer protection laws. |

Changes in the current regulatory framework for algorithmic diagnostic products and services can impose additional regulatory burdens on us. The FDA is currently considering the development of novel regulatory pathways for AI