Company: BIAF
Filing Date: 2025-05-05
Form Type: S-1/A
Source: 0001641172-25-008629
Chunk: 65

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-05
Form: S-1/A
Chunk 65
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 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 failure on our part to comply with applicable requirements, would adversely affect our business, results of operations, and financial condition.

The FDCA requires that medical devices introduced to the U.S. market, unless exempted by regulation, be authorized by the FDA pursuant to either the premarket notification pathway, known as 510(k) clearance, the de novoclassification pathway, or the premarket approval (“PMA”) pathway. We plan to seek de novoclassification for the CyPath ®Lung test in fiscal year 2028. The FDA may not agree that CyPath ®Lung meets the criteria for de novoclassification, in which case we would be required to submit a PMA to obtain marketing authorization, which would require manufacturing information and a pre-approval inspection of the manufacturing facilities and could require review by an FDA advisory panel comprised of experts outside the FDA. Any delay by or failure of the FDA to grant our de novorequest or PMA could adversely affect our consolidated revenues, results of operations, and financial condition.

Additionally, obtaining FDA marketing authorization, approval, or