bioAffinity Technologies develops and sells CyPath Lung, a noninvasive diagnostic test for early-stage lung cancer. The test targets adults at high risk for lung cancer, specifically patients whose CT scans have revealed small, indeterminate pulmonary nodules — findings that are suspicious but not conclusive for cancer. Because standard low-dose CT screening has a very low positive predictive value, many patients undergo unnecessary invasive procedures. CyPath Lung helps physicians decide whether to pursue aggressive follow-up or continue monitoring. Patients collect a sputum sample at home and ship it to bioAffinity's CLIA-certified lab in San Antonio, where it is processed, labeled with antibodies and a synthetic compound that cancer cells absorb at higher rates, and analyzed by a flow cytometer. A proprietary AI algorithm then generates a report classifying the result as "Likely Malignancy" or "Unlikely Malignancy." Physicians — primarily pulmonologists — order the test directly, and bioAffinity reaches them through a direct sales force and key opinion leader engagement. The company bills Medicare and private insurers per test. bioAffinity is currently in an early commercial ramp, having delivered just over 1,200 tests in FY25, and is expanding geographically from its Texas launch into broader U.S. markets. The company also has early-stage pipeline programs in asthma and COPD companion diagnostics and a cancer therapeutics effort it plans to develop with strategic partners. bioAffinity is pre-profitability and has funded operations through equity raises.