Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 14

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 14
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 three 2023 initiatives that came
to fruition in 2024: (1) CMS’ inclusion of reimbursement for CyPath® Lung on its 2024 clinical laboratory fee
schedule and subsequent reimbursement by Medicare and private insurance carriers; (2) the hiring of our new National Director of
Sales in late 2023 and subsequent sales persons in 2024 who are experienced and well respected in the pulmonary
field; and (3) marketing materials for the newly branded CyPath® Lung that emphasize our test’s ability to
assist physicians with next steps in patient care.

In
October 2024, CyPath® Lung was awarded listing on the U.S. Federal Supply Schedule (FSS), making the test available to
U.S. Veterans and active military personnel across government health systems. We view this market opportunity as the next step in
expanding sales nationally in the U.S., including strategic expansion into regional markets in 2025. Phase 2 of our business plan anticipates
entering the EU market with CyPath® Lung as a CE-marked IVD test beginning with sales in the Netherlands, followed by
a staged EU expansion. Phase 3 of our business plan focuses on the marketing of an FDA-cleared CyPath® Lung test, beginning
with conducting a pivotal clinical trial in the U.S. Toward that end, we have voluntarily sought FDA guidance with the intention of obtaining
clearance after completion of the pivotal trial of a Class II IVD medical device for use in the diagnosis of lung cancer in individuals
with indeterminate pulmonary nodules between 6 mm to less than 20 mm.

To differentiate our LDT test from the future FDA cleared diagnostic test,
we have named the test for which we are seeking FDA clearance “FlowPath Lung.” In December 2024, we met with FDA to discuss
our pre-submission and subsequently incorporated the requested protocol changes to improve the trial design. Our revised trial protocol
is now under review by an IRB. In third quarter 2024, the National Association of Veterans
Research and Education Foundation (“NAVREF”) extended a “Call for Interest” to VA systems to solicit participation
in the pivotal trial, which resulted in a positive response from 22 VA medical centers. We are in the process of qualifying VA, academic
and private medical centers that have asked to participate. Our Clinical Research Organization (“CRO”) is Courante Oncology.
Retired Army Col. Michael Morris, MD., of Brooke Army Medical Center has accepted