Company: BIAF
Filing Date: 2025-05-05
Form Type: S-1/A
Source: 0001641172-25-008629
Chunk: 101

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-05
Form: S-1/A
Chunk 101
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 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 lung cancer, which could lead to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs.

CyPath ®Lung uses flow cytometry technology to detect and analyze cell populations in a person’s sputum, or phlegm, to find characteristics indicative of lung cancer, including cancer and/or cancer-related cells that have shed from a lung tumor. The flow cytometer is a well-established instrument used in many commercial laboratories. Flow cytometry collects data pertaining to properties of single cells labeled with antibodies and dyes specific to cell types and characteristics. Sputum is an excellent sample for analysis because it is in direct contact with any malignancy in the lungs and can provide information about its area of field cancerization and the lung microenvironment. CyPath ®Lung uses automated data analysis developed by machine learning, a form of AI, that allows data collection and analysis of an entire sample of sputum in