Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 84

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 84
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 the College of American Pathologists (CAP), a CMS-approved
accreditation organization, and we are subject to extensive federal and certain state laws and regulations. The Food and Drug Administration (FDA) considers an LDT to be a test that is designed, developed, validated and used within a single
laboratory. The FDA has historically taken the position that it has the authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), but it has generally exercised enforcement discretion with regard to
such tests.

In May 2024, the FDA issued a final rule that took effect on July 5, 2024, amending existing regulations to provide that in vitro
diagnostic products (IVDs) are devices under the FD&C Act, including LDTs. Along with this amendment, the FDA was finalizing a policy under which the FDA will have greater oversight of IVDs offered as LDTs through a phase-out of its general enforcement discretion approach for LDTs over the course of four years. Under this new rule, LDTs may have been required to obtain premarket approval, de novo classification or 510(k)
clearance. 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 and remanded it to FDA for further consideration. The FDA elected not to appeal the U.S. District Court decision within the 60-day required window. As a result, the future of
the rule, and any enforcement approach by the FDA in this area, is uncertain.

Prior to the district court decision, we had begun to prepare for compliance with the
proposed FDA rule. Although FDA enforcement is now less likely, if FDA premarket clearance, approval or de novo classification is required, in the future, for any of our existing or future tests, or for any components or materials we use in tests,
and we are not able to obtain such clearance, approval or de novo classification, we may be forced to stop selling our tests or we may be required to modify claims for or make other changes to our tests while we or our suppliers work to obtain FDA
clearance, approval or de novo classification. The need for compliance with such FDA regulations would be time-consuming and expensive, potentially diverting resources from other aspects of our business, and we