bioAffinity Technologies starts lung cancer test validation study

bioAffinity Technologies Inc. (NASDAQ: BIAF) announced a validation study with Brooke Army Medical Center to test its CyPath Lung diagnostic on sputum samples collected through deep suction procedures.

The study will enroll 30-50 patients undergoing routine tracheal or bronchial suctioning, with results expected by mid-2026. The research aims to validate whether the CyPath Lung test can analyze suctioned sputum samples collected during bronchoscopy and other procedures, potentially expanding sample collection options beyond the current at-home collection method.

"The ability to use CyPath Lung to analyze suctioned sputum collected during bronchoscopy and other procedures would leverage samples that we are already obtaining," said Michael J. Morris, a pulmonology physician at Brooke Army Medical Center, according to the company's statement.

Currently, CyPath Lung requires patients to collect sputum samples at home and send them to laboratories for processing. The new approach would allow clinicians to use samples obtained during existing medical procedures.

Approximately 500,000 bronchoscopy procedures are performed annually in the United States, according to the company. The CyPath Lung test uses flow cytometry and artificial intelligence to identify cell populations in sputum that may indicate lung cancer.

Previous clinical studies showed the test achieved 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules smaller than 20 millimeters, based on company data.

The biotechnology company markets CyPath Lung as a laboratory developed test through its subsidiary Precision Pathology Laboratory Services. Brooke Army Medical Center, located in San Antonio, serves as the Army's academic medical center and the Department of Defense's largest hospital.

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