bioAffinity Technologies, Inc.

The company develops noninvasive diagnostic laboratory tests to detect early-stage lung cancer and other lung diseases. These tests utilize flow cytometry and automated analysis, which is enhanced by machine learning, a type of artificial intelligence (AI). Its primary commercial diagnostic test, CyPath® Lung, identifies and analyzes cell populations, including cancer and cancer-related cells, to indicate lung malignancy. CyPath® Lung is designed for noninvasive detection of early-stage lung cancer, specifically at its curative Stage 1A. Physicians order CyPath® Lung to help assess patients at high risk for lung cancer. For patients with small pulmonary nodules less than 20 millimeters (mm), CyPath® Lung demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in a clinical trial. The CyPath® Lung test is performed and offered by PPLS, a wholly owned subsidiary. PPLS is a CAP-accredited and CLIA-certified commercial clinical anatomic and pathology laboratory that has been operating for over 18 years, acquired through the purchase of assets from Village Oaks Pathology Services, P.A. Beyond CyPath® Lung, the company is developing its flow cytometry+AI platform for companion diagnostic tests aimed at asthma and chronic obstructive pulmonary disease ("COPD").