Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 92

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 92
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, 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; |

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| • |     | 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 technologies and other software. As the regulatory framework evolves, we may incur substantial costs to ensure compliance with new or amended laws and regulations. Failure to comply with any of these laws and regulations could result in enforcement actions against us or damage to our reputation, any of which could have a material adverse effect on our business, financial condition and results of operations. Our business could be harmed by the loss, suspension or other restriction on a license, certification, or accreditation, or by the imposition of a fine or penalties, under CLIA, its implementing regulations, or other state, federal and foreign laws and regulations affecting licensure or certification, or by future changes in these laws or regulations. The laboratory testing industry is subject to extensive laws and regulations, many of which have not been interpreted by the courts. CLIA requires virtually all laboratories to be certified by the federal government and mandates compliance with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely. CLIA certification is also a prerequisite to be eligible to bill state and federal health care programs, as well as many commercial third-party payors, for laboratory testing services. In addition to the CLIA certification, our laboratory is CAP-accredited,which is a voluntary program that many molecular diagnostic labs participate in. CAP is a deemed agency by the CMS for the CLIA program. As a condition of CLIA certification, our laboratory is subject to survey and inspection every two years conducted by CAP, in addition to being subject to additional CMS follow up or complaint inspections. Sanctions for failure to comply