BIAF

bioAffinity Technologies, Inc. is a biotechnology company focused on developing innovative diagnostic tests for early detection of cancer and other diseases. Headquartered in San Antonio, Texas, bioAffinity has pioneered a novel diagnostic platform based on cellular flow cytometry enhanced with proprietary chemistry that enables highly sensitive and specific detection of cancer cells and biomarkers. The company's lead focus is on lung cancer, one of the most deadly cancers globally, where early detection dramatically improves survival rates yet remains clinically challenging. bioAffinity's lead product candidate is CyPath Lung, a non-invasive diagnostic test designed to detect early-stage lung cancer using cells collected from sputum or other respiratory samples. Unlike traditional diagnostic methods requiring invasive biopsies or imaging that may miss early-stage disease, CyPath Lung uses bioAffinity's proprietary phloxine B cellular staining technology combined with flow cytometry to identify malignant and pre-malignant cells with high sensitivity and specificity. This approach could enable earlier lung cancer detection, particularly for high-risk individuals such as smokers and former smokers. The company has conducted clinical validation studies demonstrating CyPath Lung's performance characteristics and is working toward regulatory clearance and commercialization. bioAffinity's technology platform extends beyond lung cancer to potentially detect other cancers and diseases where cellular analysis can provide diagnostic insights. The lung cancer diagnostic market represents a substantial opportunity given the disease's high prevalence, mortality rate, and the clinical need for better early detection tools. bioAffinity's success depends on completing regulatory pathways (FDA clearance), demonstrating clinical utility, establishing reimbursement coverage, building commercial infrastructure, and achieving physician and patient adoption. The company's non-invasive approach and proprietary staining technology differentiate its offering from existing lung cancer screening and diagnostic methods.