Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 80

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 80
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 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 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 FDA enforcement is not 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
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 pay