Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 215

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 215
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 trademarks or trade names. If we assert
trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party
against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately
be forced to cease use of such trademarks.

Risks
Related to Government Regulations

CyPath®
Lung is currently being offered as an LDT by PPLS. Should the FDA disagree that CyPath® Lung is an LDT, or if the
FDA’s regulatory approach to LDTs should change in the future, our commercialization strategy may be adversely affected, which
would negatively affect our results of operations and financial condition.

The
FDA considers an LDT to be a test that is developed, validated, and performed within a single laboratory. The FDA has historically asserted
its authority to regulate LDTs as medical devices under the FDCA, but it has generally exercised enforcement discretion with regard to
LDTs. This means that even though the FDA believes it can impose regulatory requirements on LDTs, such as requirements to obtain premarket
approval, de novo classification, or clearance of LDTs, it has generally chosen not to enforce those requirements. The FDA has,
on occasion, sent warning letters to laboratories offering LDTs that the agency believed were not eligible for enforcement discretion
because of how they were developed, validated, performed, or marketed and consequent risks to the public.

 42 

On
May 6, 2024, FDA promulgated a final rule phasing out over four years its enforcement discretion over LDTs. The agency states it will
expect compliance with premarket review and quality system requirements for LDTs marketed after May 6, 2024. The FDA states that the
agency will generally not enforce premarket review requirements for LDTs that were marketed before May 6, 2024, if they are not modified
in certain ways. In particular, the rule states that the LDT is exempt if marketed before May 6, 2024, and is not modified in a way that
changes its indications for use; does not alter its operating principle; does not include significantly different technology; and, the
LDT does not adversely change its performance or safety specifications. The Company has no expectation or intention to modify CyPath®
Lung in any manner that will change its indications for use, alter its operating principal