Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 0

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 0
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Business
Overview

We develop proprietary 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 artificial
intelligence (“AI”). Our diagnostic tests analyze cell populations, including cancer and cancer-related cells, that are indicative
of a specific diseased state.

We were formed as a Delaware corporation on March 26, 2014. On June 15,
2016, we formed OncoSelect® Therapeutics, LLC (“OncoSelect®”), a Delaware limited liability
company and our wholly owned subsidiary which is a preclinical-stage biopharmaceutical discovery company that has advanced our discoveries
of novel potential cancer therapies that specifically and selectively target a broad spectrum of cancer cells that have been grown in
petri dishes without harm to healthy cells. We expect to present our findings at conferences and publish the results of our research this
year and seek strategic partners that have the resources to advance our therapeutic discoveries.

On
August 14, 2023, we formed Precision Pathology Laboratory Services, LLC (“PPLS”), a Texas limited liability company and our
wholly owned subsidiary, which performs our clinical laboratory services, including CyPath® Lung operations. Research
and optimization of our platform technologies for in vitro diagnostics and therapeutic technologies are conducted in laboratories at
The University of Texas at San Antonio and PPLS in San Antonio, Texas.

In September 2023, through our wholly owned subsidiary PPLS, we acquired
the assets of Village Oaks Pathology Services, P.A. (“Village Oaks”), a Texas professional association d/b/a Precision Pathology
Services, including a clinical anatomic and clinical pathology laboratory and related services business in San Antonio, Texas. The laboratory
is accredited by the College of American Pathologists (“CAP”) and certified under the Clinical Laboratory Improvement Amendments
of 1988 (“CLIA”). 

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 and
care 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