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.
AstraZeneca reports positive Phase III survival results for Sone-Ve in advanced gastric cancers
Faron reports encouraging first overall survival data from BEXMAB frontline HR-MDS trial
Active Biotech doses first patient in amended tasquinimod myelofibrosis study
Ipsen's Phase III BOLD trial misses primary endpoint in biliary atresia
Sanofi ends atopic dermatitis development for amlitelimab
ArkBio completes Australian dosing in Phase I trial of influenza AFC drug AK0406
Synaptiq Therapeutics launches and acquires clinical-stage SYN-001 programme
Bio-Thera Solutions reports first patient dosed in Phase 1 study of BAT8013
EU approves AstraZeneca's Etcamah combination for 1st-line ER-positive advanced breast cancer
BeOne Medicines expands US manufacturing with USD300m investment
FDA grants Fast Track designation to Lundbeck's narcolepsy candidate Lu AH69593
Dassault Systèmes to acquire ArisGlobal in up to USD2bn deal