Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 70

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 70
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 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 did not 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.

Prior to the district court decision, we had begun to prepare for compliance with the
proposed FDA rule. Although the FDA’s enforcement approach is now uncertain, 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 could be subject to
legal actions, including fines and penalties, if we fail to comply with these requirements, any of which may adversely impact our business and results of operations. Our business could be adversely affected while such review is ongoing, and if we or
our supplier are ultimately unable to obtain premarket clearance, approval or de novo classification. In addition, we may require cooperation in our filings for FDA clearance, approval or de novo classification from third-party manufacturers of the
components of our tests. If we are unable to obtain such required cooperation, we may be unable to achieve the desired regulatory clearances, approvals or de novo classifications or may be delayed or be required to expend additional costs and other
resources in doing so. Moreover, if FDA premarket clearance, approval or de novo classification is required, our revenue or cash flows may be adversely affected until we obtain such clearance, approval or de novo classification, as most third-party
payors, including Medicaid, will not reimburse for use of medical devices which are required to, but which do not, have marketing authorization.

Furthermore, the
FDA or the Federal Trade Commission (FTC), as well as state consumer protection agencies, may object to the materials and methods we use to promote the use of our current tests or other LDTs we may develop