bioAffinity Technologies

bioAffinity Technologies

bioAffinity Technologies was founded in 2014 by President and CEO Maria Zannes to commercialize research originating at Los Alamos National Laboratory. The underlying science uses a fluorescent biomarker, TCPP, to label cancer cells for detection. An initial clinical trial on New Mexico military veterans established TCPP as a viable marker, and the company has since focused on refining a flow cytometry-based test called CyPath Lung. The firm's core strategy centers on a proprietary laboratory-developed test. CyPath Lung analyzes sputum samples using flow cytometry and artificial intelligence to identify cell populations altered by lung cancer. A 2023 study published in Respiratory Research reported 92% sensitivity and 87% specificity in high-risk patients with small pulmonary nodules, with more than half of detected cancers at Stage I or II. The test is processed in a CAP-accredited, CLIA-certified laboratory operated by the firm's subsidiary, Precision Pathology Laboratory Services, which also serves outpatient physicians with general pathology services. The company, headquartered in San Antonio, operates additional research laboratories at The University of Texas at San Antonio. It went public via an initial offering in September 2022 and subsequently acquired Precision Pathology Services in 2023. In May 2026, bioAffinity Technologies reported record monthly CyPath Lung unit sales and significant year-over-year growth (per the firm, May 2026). A new study to expand CyPath technology into asthma and COPD diagnosis was launched in April 2026. bioAffinity Technologies embeds its commercial lab directly within its corporate structure, a departure from the common model of out-licensing diagnostics to larger reference labs. This vertical integration allows the firm to control the full revenue cycle — from physician sales to Medicare reimbursement — while publishing physician case studies on curative Stage 1A detections that build clinical adoption.