Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 227

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 227
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 “For Research Use Only. Not for Use in Diagnostic Procedures.” Manufacturers of RUO products cannot make any claims related to safety, effectiveness or
diagnostic utility, and RUO products cannot be intended by the manufacturer for clinical diagnostic use. An RUO product promoted for diagnostic use may be viewed by the FDA as adulterated and misbranded under the FDC Act and the manufacturer of such
product could be subject to FDA enforcement activities. Our laboratory-developed tests (LDTs) use instruments and reagents labeled as RUO.

Laboratory-developed tests. Each of our genetic tests is an LDT. The FDA considers LDTs to be tests that are designed, developed, validated and used within a
single laboratory. The FDA historically has taken the position that it has the authority to regulate such tests as medical devices under the FDC Act but had historically exercised enforcement discretion and did not require clearance, de novo
classification, or approval of most LDTs prior to marketing. As a result, our molecular diagnostic products are not subject to FDA approval requirements.

In
May 2024, the FDA published a final rule amending the definition 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.