Company: BIAF
Filing Date: 2025-10-09
Form Type: 424B5
Source: 0001493152-25-017591
Chunk: 68

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-10-09
Form: 424B5
Chunk 68
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 would expressly grant the FDA authority to regulate LDTs under a risk-based framework; and the VITAL Act, which would assign LDTs to regulation solely under CLIA and would direct CMS to update its CLIA regulations. We cannot predict if either of these bills will be enacted in their current (or any other) form and cannot quantify the effect of these bills on our business. In the meantime, the regulation by the FDA of LDTs remains uncertain.

If FDA premarket review, classification or approval is required for CyPath ®Lung before we obtain de novoclassification, our phased strategy for market entry would be adversely affected. Our laboratory licensee, PPLS, could be forced to stop marketing CyPath ®Lung while we work to obtain de novoclassification. Our business, results of operations and financial condition would be negatively affected unless and until such review were completed and our request for de novoclassification were granted.

Although we do intend to conduct clinical trials in order to receive clearance from the FDA as a Class II in vitro diagnostic, there can be no assurance that the trial will have favorable results or that it will generate the results necessary to obtain such clearance.

Delay by or failure of the FDA to grant our request for de 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 United States 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 the second quarter of 2026. The FDA may not agree that 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 de novoclassification for diagnostics can be expensive, time consuming and uncertain, and for higher-risk devices can take several years and requires detailed and comprehensive scientific