Biotechnology company bioAffinity Technologies Inc (Nasdaq: BIAF; BIAFW) on Monday announced positive results from its Texas-based beta launch of CyPath Lung, the company's noninvasive test for early-stage lung cancer. In 2024, over 600 tests were delivered during the pilot marketing program, highlighting strong initial market uptake.
CyPath Lung demonstrated a 92% sensitivity and 87% specificity in high-risk patients with nodules under 20 millimeters. More than half of the cancer cases detected were early-stage (Stage I or II), with the test identifying adenocarcinoma, squamous cell carcinoma, and small cell lung cancer.
The test uses advanced flow cytometry and AI to analyze sputum samples for malignancy, offering a promising tool for early cancer detection.
Key figures in the study included Dr Michael J. Morris from Brooke Army Medical Center and Dr Sheila A. Habib from the South Texas Veterans Health Care System, with the findings published in the Journal of Health Economics and Outcomes Research.
CyPath Lung is marketed as a Laboratory Developed Test (LDT) through Precision Pathology Laboratory Services, a bioAffinity subsidiary. The company continues to refine its platform technologies in collaboration with The University of Texas at San Antonio.
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