bioAffinity Technologies Initiates Planned Longitudinal Clinical Study For CyPath Lung, Noninvasive Diagnostic Test For Detection Of Early-Stage Lung Cancer

Study to evaluate clinical performance of CyPath® Lung for the early detection of lung cancer in high-risk patients

Murtha Cancer Center Research Program at Uniformed Services University of the Health Sciences provides support for longitudinal study

bioAffinity Technologies, Inc. (NASDAQ:BIAF, BIAFW)),a biotechnology company focused on non-invasive diagnostics and early cancer detection, today announced initiation of the Company's planned large-scale, longitudinal clinical study for CyPath® Lung, its noninvasive diagnostic test for the detection of early-stage lung cancer.

The 2,000-patient longitudinal study is designed to evaluate the clinical performance of the CyPath® Lung flow cytometry test as a noninvasive diagnostic that uses sputum samples to detect the presence of lung cancer in high-risk individuals with existing lung nodules six millimeters (mm) to less than 30 mm in diameter identified by lung cancer screening. In an earlier clinical trial, CyPath® Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients with small pulmonary nodules less than 20mm. Several recent patient case studies demonstrate the test's ability to detect lung cancer at its curative Stage 1A.

bioAffinity Technologies expects up to 20 clinical study sites, including a dozen Department of Veterans Affairs (VA) medical centers and two of the nation's largest military hospitals, will participate in the study. Michael J. Morris, MD, pulmonology and critical care physician at Brooke Army Medical Center, is the national Principal Investigator for the study (NCT07168993). The John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is providing support and funding associated with the trial at several federal facilities.

Physicians currently order CyPath® Lung, a laboratory developed test (LDT) offered by bioAffinity Technologies' subsidiary Precision Pathology Laboratory Services, for their patients with indeterminate lung nodules to determine next steps in patient care.

The longitudinal clinical trial announced today will evaluate FlowPath Lung, a research-use test that uses the same technology and follows the same procedures as CyPath® Lung. The different name is simply used to distinguish the investigational assay from the commercially available test.