Study Begins for bioAffinity Technologies’ CyPath Lung Cancer Diagnostic

bioAffinity Technologies Inc. has initiated a planned large-scale, longitudinal clinical study for CyPath Lung, its noninvasive diagnostic test for detecting 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 lung cancer in high-risk individuals with existing lung nodules six millimeters to less than 30 mm in diameter. 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 20 mm. Several recent patient case studies demonstrate the test’s ability to detect lung cancer at its curative Stage 1A.

“Initiating this study represents an important milestone for CyPath Lung,” bioAffinity Technologies President/CEO Maria Zannes stated. “By following patients longitudinally across multiple sites, we expect to acquire robust, real-world data that reflects how CyPath Lung may be used to support risk assessment and clinical decision-making aligned with our objective to establish CyPath Lung as a standard of care for evaluating patients at high-risk for early-stage lung cancer.”

bioAffinity Technologies expects up to 20 clinical study sites, including a dozen U.S. Department of Veterans Affairs (VA) medical centers and two of the nation’s largest military hospitals, to participate in the study. Michael J. Morris, M.D., a pulmonology and critical care physician at Brooke Army Medical Center, is the study’s national principal investigator. 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, Md., 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 patients with indeterminate lung nodules to determine the next steps in patient care.

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

“As more indeterminate pulmonary nodules are found either incidentally or by routine lung cancer screening, CyPath Lung can fill the diagnostic gap between ‘watchful waiting’ and invasive procedures that carry risk,” bioAffinity Technologies Chief Medical Officer Gordon Downie, M.D., Ph.D., commented. “As a result, we see growing adoption and use of CyPath Lung by physicians and expect this longitudinal trial to provide additional evidence to support inclusion of our noninvasive test as part of the standard of care for lung cancer screening and diagnosis.”

The study includes participation from several federal facilities to examine the test’s performance in diverse patient populations, including military service members and veterans. Patient enrollment is expected to take up to 18 months with patients followed for up to 24 months or until a definitive diagnosis of cancer or no cancer is determined.

CyPath Lung is a non-invasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.

bioAffinity Technologies Inc. addresses the need for non-invasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The company’s first product, CyPath Lung, is a non-invasive test that has shown high sensitivity, specificity, and accuracy for detecting early-stage lung cancer.