bioAffinity Technologies (NASDAQ:BIAF) announced on March 10, 2026, the launch of a large longitudinal clinical study involving 2,000 patients to evaluate the performance of its CyPath® Lung technology for early detection of lung cancer in individuals at high risk who have indeterminate lung nodules.
The trial will utilize FlowPath Lung, an investigational version of the company’s sputum-based flow cytometry test, to monitor participants for up to 24 months. The study is expected to take place at as many as 20 clinical sites, including approximately a dozen Veterans Affairs medical centers and two major military hospitals.
The research is supported and partially funded by the John P. Murtha Cancer Center Research Program at the Uniformed Services University. According to the company, the study aims to generate extensive real-world clinical data from a broad population that includes both military personnel and veterans.
bioAffinity views the trial as a significant step toward positioning CyPath® Lung as a potential component of standard clinical practice. If successful, the company believes the test could increase physician adoption of its noninvasive diagnostic approach, helping bridge the gap between watchful waiting and more invasive procedures used in lung cancer evaluation.
More about bioAffinity Technologies
bioAffinity Technologies, Inc. is a biotechnology company focused on noninvasive diagnostic solutions and early detection of cancer, particularly lung disease. Its lead product, CyPath® Lung, is a laboratory-developed test that analyzes sputum samples using flow cytometry combined with artificial intelligence to identify early-stage lung cancer in high-risk individuals.
In earlier clinical studies, CyPath® Lung demonstrated strong diagnostic performance, achieving 92% sensitivity, 87% specificity and 88% overall accuracy in detecting lung cancer among patients with small indeterminate pulmonary nodules.
The test is marketed through the company’s subsidiary, Precision Pathology Laboratory Services, and is designed to support improved diagnosis and risk assessment in lung cancer screening populations.