bioAffinity Technologies Business Summary

bioAffinity Technologies, Inc. (BIAF) is a commercial-stage biotechnology firm specializing in non-invasive diagnostic tests and targeted cancer therapeutics. The company generates primary revenue through the commercial sale of its flagship product, CyPath Lung, a sputum-based Laboratory Developed Test (LDT) processed via flow cytometry and proprietary AI algorithms. Following a strategic pivot in late 2025, the company discontinued its legacy pathology services to focus resources on the high-growth diagnostic segment and its therapeutic pipeline, which leverages porphyrin-based technology to preferentially target malignant cells. bioAffinity operates within the competitive early-detection oncology market, positioned as a specialized risk-stratification tool for high-risk patients with indeterminate lung nodules. It competes directly with liquid biopsy and diagnostic leaders such as Biodesix (BDSX), Guardant Health (GH), Veracyte (VCYT), and Grail, distinguishing itself through a 92% sensitivity rate and a focus on reducing the clinical burden of unnecessary invasive biopsies. The company is led by a founding team with deep pedigrees in healthcare marketing and public policy. President and CEO Maria Zannes, J.D., brings over 30 years of executive experience, having previously served as a legislative aide to Congressman Charles Wilson and as President of the Energy Recovery Council. Executive Chairman Steven Girgenti is a veteran healthcare executive who founded Healthworld Corporation (acquired by WPP) and was named NASDAQ Entrepreneur of the Year. The broader leadership team includes CFO J. Michael Edwards, COO Xavier Reveles, and Chief Science Officer William Bauta, Ph.D., who oversees the firm’s medicinal chemistry and discovery efforts. Notable board members include Peter S. Knight, a founding partner of Generation Investment Management alongside Al Gore and former campaign manager for President Bill Clinton, and Robert A. Anderson, a former marketing executive at Schering-Plough and Centocor (Johnson & Johnson).