Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 69

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 69
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 are obtained, once the patent life has expired, we may be open to competition. Given the amount of time required for the development, testing and regulatory review of our new products or
technologies, patents protecting them might expire before or shortly after they are commercialized. As a result, our patent portfolio may not provide us with a sufficient exclusivity period to exclude others from commercializing products similar or
identical to ours.

Further, recent judicial decisions in the U.S. raised questions regarding the award of patent term adjustment (PTA) for patents in families where
related patents have issued without PTA. Thus, it cannot be said with certainty how PTA will be viewed in the future and whether patent expiration dates may be impacted.

Risks related to legal and regulatory matters

Our tests are currently marketed as LDTs, and future changes in FDA enforcement of LDTs could subject our operations to much more significant regulatory requirements.

We currently
offer a number of genetic tests, each of which is a laboratory developed test (LDT). Our laboratories are currently regulated under Clinical Laboratory Improvement Amendments of 1988 (CLIA) and

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we have elected to comply with the higher standards and requirements established by 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