Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 246

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 246
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 of an IVD device to include LDTs and classifying LDTs as medical devices subject to FDA regulation. Under the final rule, all LDTs, unless subject to a specific exemption, would have been
subject to premarket authorization requirements (510(k), de novo classification, or PMA), and laboratories performing LDTs would have needed to comply with post-market registration and listing, medical device reporting, correction, removal and
recall, complaint handling, labeling, investigational device, and quality system requirements. The FDA intended to phase in these requirements beginning in May 2025. The final rule stated that certain categories of LDTs would be subject to
enforcement discretion with respect to some or all of these requirements. For example, FDA intended to apply enforcement discretion to currently marketed LDTs that were first offered prior to May 6, 2024, with respect to most quality system
requirements and the requirement for premarket authorization if they are not modified or modified in only limited ways, but such LDTs would have remained subject to the other requirements discussed above. The FDA intended to similarly exercise
enforcement discretion with respect to premarket authorization for LDTs approved by the New York State Clinical Laboratory Evaluation Program. Under the final rule, most, but not all, of our LDTs may have been eligible for enforcement discretion.

On March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the final rule in its entirety, holding that the FDA’s attempt to
regulate professional laboratory testing services as medical devices exceeds the authority granted to the FDA. The FDA elected not to appeal the U.S. District Court decision within the required 60-day required window. As a result, the future of the
rule, and any enforcement approach by the FDA in this area, is uncertain.

Clinical Laboratory Improvement Amendments of 1988, College of American Pathologists, and state regulations

Clinical Laboratory Improvement Amendments (CLIA)

As a clinical laboratory, we are required to hold certain federal and state licenses, certifications or permits to conduct our business. As to federal certifications,
the Clinical Laboratory Improvement Amendments of 1988 (CLIA) establishes rigorous quality standards for all commercial laboratories that perform testing on human

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specimens for the purpose of providing information for the diagnosis, prevention, or treatment of disease or the assessment of the health or impairment of human beings. CLIA requires such
laboratories to be certified by the federal government and mandates compliance