Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 124

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 124
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 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, include different technology, or change its performance or safety specifications.

On May 6, 2024, FDA promulgated the LDT Final Rule phasing out over four years its enforcement discretion over LDTs. The agency stated that it expected compliance with premarket review and quality system requirements for LDTs marketed after May 6, 2024. The FDA stated 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 or include different technology, or change its performance or safety specifications.

Within weeks of the FDA issuing the LDT Final Rule, lawsuits were filed challenging the rule claiming it is “in excess of the agency’s statutory jurisdiction, authority, or limitations and is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law”. On March 31, 2025, the U.S. District Court for the Eastern District of Texas entered a judgment in favor of the plaintiffs. In its Opinion and Order, the Court states that, “the text, structure, and history of the FDCA and CLIA make clear that FDA lacks the authority to regulate laboratory-developed test services”. Throughout its opinion, the Court outlines its disagreement with the FDA’s expansion and interpretation of the definition of “device” and the agency’s overall interpretation of its authority to regulate LDTs under the FDCA. ( See 5 U.S.C. § 706(2)).

Specifically, the Court states LDTs are services regulated under CLIA, for which CMS is primarily responsible for issuing