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.
Creo Medical Group plc launches robotic-guided lung ablation procedures in the UK
Phase I/II clinical trial of Ariceum Therapeutics' 225Ac-SSO110 gets US FDA approval
HUTCHMED receives full NMPA approval for ORPATHYS in China for MET exon 14 skipping NSCLC
bioAffinity Technologies declares successful beta launch of CyPath Lung in Texas
hVIVO completes pilot study for hMPV challenge model
RYBREVANT plus LAZCLUZE shows significant improvement in overall survival for lung cancer, says J&J
BerGenBio initiates lung cancer trial with bemcentinib and pacritinib
Nuvation Bio secures NMPA approval for taletrectinib in China