bioAffinity’s CyPath Lung Test Now Available to U.S. Veterans

bioAffinity Technologies Inc.’s early-stage lung cancer detection test has been added to the U.S. Federal Supply Schedule, thereby ensuring its availability to U.S. veterans and military personnel.

The Veterans Health Administration (VHA)—part of the U.S. Department of Veterans Affairs (VA)—serves 9.1 million veterans annually and is the nation’s largest integrated healthcare system, providing care at 1,380 healthcare facilities, including 170 medical centers and 1,193 VHA outpatient clinics. Approximately 8,000 veterans are diagnosed and treated for lung cancer annually, according to the VA.

“Lung cancer is the leading cause of cancer-related death in veterans, despite being one of the most preventable cancers in the world. The University of California, Irvine School of Medicine reports that an estimated 15 veterans die of lung cancer each day, and veterans are 25% more likely to receive a lung cancer diagnosis compared to non-veterans,” bioAffinity President/CEO Maria Zannes said. “My father was one such veteran who died from lung cancer at age 39. That is just one of many reasons I am immensely proud that VA and Department of Defense physicians will be able to order CyPath Lung for their patients to help detect early-stage lung cancer with the goal of leading to better treatment and longer lives.”

Veterans are at higher risk for lung cancer due to older age, smoking, and environmental exposure during and after military service. CyPath Lung is effective for patients who receive a positive screening result. When a low dose computed tomography (LDCT) scan reveals indeterminate pulmonary nodules, CyPath Lung helps close the gap between a “wait and see” option and an invasive procedure, including biopsy, that may turn out to be unnecessary.

A recent economic impact study found that adding CyPath Lung to the current standard of care could save hundreds of millions of dollars annually in healthcare costs by reducing follow-up diagnostic assessments, expensive follow-up procedures and procedure-related complications.

“Both as a veteran who was honored to serve and as the medical director for the lab that developed CyPath Lung to detect this deadly cancer, I am proud to partner with the VA and the Military Health System to help improve health outcomes for the millions of veterans and active-duty military who are at higher risk for lung cancer,” stated retired Col. Roby Joyce, M.D., medical director of bioAffinity’s subsidiary laboratory, Precision Pathology Laboratory Services, and a bioAffinity board member who served in the U.S. Army Medical Corps for 15 years. “It’s gratifying to see the VA acknowledge CyPath Lung as a valuable tool for the early diagnosis of lung cancer, which affects far too many past and present members of our military.”

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. The non-invasive CyPath Lung incorporates a fluorescent porphyrin, meso-tetra (4-carboxyphenyl) porphyrin (TCPP), that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters.

bioAffinity Technologies Inc. addresses the need for noninvasive diagnosis of early-stage cancer and lung diseases and broad-spectrum cancer treatments. The company’s first product, CyPath Lung, is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.