Company: BIAF
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023405
Chunk: 33

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 8
Chunk 33
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 those identified
below, and those discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2024, as may be amended, supplemented or superseded from time to time by other reports we file with the SEC.
All amounts in this report are in U.S. dollars, unless otherwise noted.

Company
Overview

Business

We
develop noninvasive diagnostics to detect early-stage lung cancer and other diseases of the lung using flow cytometry and automated analysis
developed by machine learning, a form of AI. One of our diagnostic tests analyzes cell populations, including cancer and cancer-related
cells, that are indicative of a specific diseased state.

Our
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 screening in accordance with guidelines. 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.

Commercial
laboratory services, including CyPath® Lung, are performed at our wholly owned subsidiary PPLS which we acquired by purchasing
the assets of Village Oaks Pathology Services, P.A., a Texas professional association d/b/a Precision Pathology Services, that included
the CAP-accredited and CLIA-certified commercial laboratory it owned. We own and operate the clinical anatomic and clinical pathology
laboratory. CyPath® Lung is offered for sale to physicians by PPLS.

We
continue to advance development of our flow cytometry+AI platform for diagnostic tests targeted at COPD and asthma. Diagnostics under
development are designed to detect specific receptors in sputum that determine the effectiveness of new and emerging therapies for asthma
and COPD that have proved to effectively treat some but not all patients.

Through
our wholly owned subsidiary, OncoSelect® Therapeutics, LLC, we have conducted research that has led to discoveries and
advancement of novel cancer therapeutic approaches that specifically and selectively target cancer cells. We continue to advance research
and development for