bioAffinity Technologies Working With U.S. Army on CyPath Lung Study

bioAffinity Technologies Inc. is partnering with Brooke Army Medical Center (BAMC) on a study to determine the efficacy of the CyPath Lung diagnostic test in assessing sputum samples for early lung cancer detection.

The study aims to enroll approximately 30 to 50 patients undergoing routine tracheal or bronchial suctioning, with results from the study expected by the middle of this year. Validating the performance of CyPath Lung analysis on deep suction samples could potentially expand CyPath Lung’s versatility and support broader use in detecting early-stage lung cancer.

“CyPath Lung is a novel, noninvasive adjuvant diagnostic for patients at high risk for lung cancer,” said Michael J. Morris, M.D., pulmonology and critical care physician at BAMC. “The ability to use CyPath Lung to analyze suctioned sputum collected during bronchoscopy and other procedures would leverage samples that we are already obtaining and expand access to earlier, more informed decision-making for patients at risk.”

Under the standard protocol for the CyPath Lung test, patients with suspicious pulmonary nodules collect a sputum sample at home and send the sample overnight to the lab for processing. The deep suction study attempts to expand the options for sample collection by validating CyPath Lung’s use with suctioned sputum samples conducted in the clinic while patients undergo bronchial and tracheal suction procedures. Bronchial and tracheal suction may be used to clear airways and improve oxygenation. When used in conjunction with bronchoscopy, a suction catheter gently aspirates secretions from areas of concern within the lungs, which can provide robust samples to obtain diagnostic information.

“Clinicians who have patients scheduled to undergo diagnostic bronchoscopy have told us that CyPath Lung could be very helpful by providing an independent and complementary test for diagnosis,” bioAffinity Technologies Chief Medical Officer Gordon Downie, M.D., Ph.D., stated. “Physicians tell us they need additional tools for diagnosing indeterminate lung nodules, and this study demonstrates that we are listening to the clinicians using CyPath Lung and responding to their needs.”

Bronchoscopy is commonly used in the United States, with approximately 500,000 procedures performed annually. The U.S. bronchoscopy procedure market, including devices and related technologies, is valued at $700 milliion to $920 million and continues to grow, driven by the rising prevalence of lung disease, including cancer and COPD, and adoption of innovative diagnostic tools. The CyPath Lung study with BAMC will explore an approach that could expand the utility of bronchoscopy-collected samples for earlier, noninvasive lung cancer detection.

“BAMC is a leader in medical research with access to a large patient population representing the full range of pulmonary health,” bioAffinity Technologies President/CEO Maria Zannes commented. “We look forward to collaborating with BAMC and the potential to expand the reach of the AI-driven technology behind CyPath Lung to detect lung cancer at the earliest, most treatable stage.”

Brooke Army Medical Center (BAMC), located at Joint Base San Antonio-Fort Sam Houston, Texas, is the U.S. Army’s academic medical center and the Department of War’s largest hospital. BAMC provides inpatient and outpatient care to active-duty service members, veterans, their families, and civilian patients, supported by more than 8,000 military and civilian personnel. The center also serves as a teaching hospital and research institution with advanced specialty services, graduate medical education, and rehabilitation programs.

CyPath Lung is a noninvasive 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 patients’ 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 addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung 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.