Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 64

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 64
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 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 implementing regulations. The Court notes that Congress created a separate statutory and regulatory framework for laboratory test services under CLIA. In its opinion, the Court defines an LDT as “a methodology or process by which a laboratory generates biochemical, genetic, molecular, or other forms of clinical information about a patient specimen for use by the treating physician” and that “[e]ach laboratory uses its own unique knowledge of the protocols, performance characteristics, and means of analysis to develop such methodologies and processes”.

By employing this particular definition of LDTs, the Court claims that LDTs are services that laboratory professionals perform rather than a physical product sold by a laboratory that could be subject to FDA jurisdiction as a device. As a result, the Court vacated and set aside the LDT Final Rule in its entirety, holding that the LDT Final Rule exceeds the FDA’s statutory authority and violates the Administrative Procedures Act (APA). Due to the Court’s order, the LDT Final Rule will not go into effect as planned in May 2025. Unless appealed by the government, this ruling essentially halts the FDA’s ability to promulgate further regulations or guidance regulating LDTs.

Delay by or failure of the FDA to grant our request forde novo classification, or