- Business
- bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) is a biotechnology company that develops noninvasive diagnostics for early-stage lung cancer and other lung diseases using flow cytometry and AI-driven automated analysis; it also advances broad-spectrum cancer therapeutics through its subsidiary OncoSelect Therapeutics. The company's primary product, CyPath Lung, is a laboratory-developed test (LDT) marketed by its wholly owned subsidiary Precision Pathology Laboratory Services (PPLS), employing a porphyrin molecule with high affinity for cancer cells to label and distinguish malignant from non-malignant cells in patient sputum samples, achieving 92% sensitivity and 87% specificity for nodules under 20 mm; CyPath Lung aids clinical decision-making following suspicious low-dose computed tomography results in high-risk patients. Operations span diagnostic research and development alongside laboratory services, targeting pulmonologists, high-risk lung cancer patients, and healthcare providers in the United States, with headquarters in San Antonio, Texas, where the company was founded in 2014.
In recent developments, bioAffinity Technologies acquired Precision Pathology Laboratory Services in September 2023, driving over 20% annualized revenue growth to approximately $9.4 million in 2024 from PPLS, fueled by a 1,750% surge in CyPath Lung sales through November 2024 compared to the prior year. The company secured reimbursement for CyPath Lung, expanded its sales team, gained access to the federal healthcare system, and streamlined laboratory operations by discontinuing unprofitable pathology services to prioritize CyPath Lung commercialization. In 2025, bioAffinity raised $10.4 million in gross proceeds from third-quarter equity transactions to support growth; issued four patient case studies highlighting CyPath Lung's role in Stage 1A detections; expanded its intellectual property with a U.S. patent on its proprietary algorithm; and appointed Roberto Rios, CPA, and John J. Oppenheimer, M.D., to its board.