Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 7

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 7
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 early-stage research focused on advancing therapeutic discoveries that
could result in broad-spectrum cancer treatments. We have developed a proprietary noninvasive diagnostic test using technology that identifies
cancer cells and cell populations indicative of a diseased state for analysis using proprietary platforms developed using artificial intelligence
(“AI”). Research and optimization of our platform technologies are conducted in laboratories at The University of Texas at
San Antonio and at our wholly owned subsidiary, Precision Pathology Laboratory Services, LLC (“PPLS”).

Our first diagnostic test, CyPath
Lung, addresses the need for noninvasive detection of early-stage lung cancer. Lung cancer is the leading cause of cancer-related deaths
worldwide. Physicians order CyPath Lung to assist in their assessment of patients who are at high risk for lung cancer.
The CyPath Lung test enables physicians to more confidently identify patients who will likely benefit from timely intervention
and more invasive follow-up procedures and those who are likely without lung cancer and should continue routine screening. CyPath
Lung has the potential to increase overall diagnostic accuracy of lung cancer, which could lead to increased survival, fewer unnecessary
invasive procedures, reduced patient anxiety, and lower medical costs.

Through our wholly owned subsidiary, OncoSelect
Therapeutics, LLC, our research has led to discoveries and advancement of novel cancer therapeutic approaches that specifically and selectively
target cancer cells. We are focused on expanding our broad-spectrum platform technologies to develop tests that detect and therapies that
target various types of cancer and potentially other diseases.

Through our wholly owned subsidiary PPLS, we acquired
the assets of Village Oaks Pathology Services, P.A., a Texas professional association d/b/a Precision Pathology Services, including the
clinical pathology laboratory it owned, and we now operate the laboratory. The laboratory is accredited by the College of American Pathologists
(“CAP”) and certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).

Recent Developments

FDA Pivotal Study

In March 2025, we submitted our pivotal clinical trial
protocol “Detection of Early-Stage Lung Cancer in Sputum using Flow Cytometry and an Automated Analysis Pipeline” to the Sterling
Institutional Review Board (“IRB”) for approval after the Company met with the U.S. Food and Drug Administration (“FDA”)
on trial design. In the third quarter of 2024, the National Association of Veterans Research and Education Foundation (“NAVREF”)
extended a “Call for Interest” to Veterans Administration (“VA”)