bioAffinity Technologies Initiates Study with Brooke Army Medical Center to Expand Early Lung Cancer Detection Using CyPath® Lung Test
bioAffinity Technologies, Inc. a leading biotechnology company dedicated to advancing noninvasive diagnostics and early cancer detection, has announced a groundbreaking study in partnership with Brooke Army Medical Center (BAMC). The study aims to validate the clinical utility of bioAffinity’s proprietary CyPath® Lung diagnostic test using sputum samples collected through tracheal and bronchial suctioning, potentially marking a significant step forward in the early detection of lung cancer.
The CyPath® Lung test is a novel diagnostic technology designed to provide clinicians with noninvasive tools to detect lung cancer at its earliest stages. Traditionally, patients collect a sputum sample at home, which is then sent overnight to bioAffinity’s laboratory for advanced AI-driven analysis. This new study seeks to assess whether CyPath® Lung can also effectively analyze sputum samples obtained during routine bronchoscopy or other procedures that involve deep suctioning of the trachea and bronchi. If validated, this approach could broaden the test’s versatility and increase access to timely, actionable diagnostic information for patients at high risk of lung cancer.
Dr. Michael J. Morris, a pulmonology and critical care physician at BAMC, highlighted the potential impact of the study, stating, “CyPath® Lung is a novel, noninvasive adjuvant diagnostic for patients at high risk for lung cancer. 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.”
The study is designed to enroll between 30 and 50 patients who are already undergoing routine tracheal or bronchial suctioning procedures. Researchers anticipate that results from this investigation will be available by mid-2026. By validating CyPath® Lung for use with these suctioned sputum samples, bioAffinity aims to enhance the diagnostic toolkit available to physicians, especially for patients with indeterminate pulmonary nodules.
Dr. Gordon Downie, Chief Medical Officer of bioAffinity Technologies, emphasized the importance of clinician input in shaping the study. “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,” Dr. Downie explained. “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.”
Expanding Sample Collection Options
Currently, the standard protocol for CyPath® Lung involves patients collecting sputum at home. The new deep suction study, however, is designed to expand these options by validating the test’s effectiveness on samples collected in a clinical setting during bronchial or tracheal suctioning procedures. These procedures, commonly performed during bronchoscopy, are used to clear the airways, improve oxygenation, and aspirate secretions from specific areas of the lungs. This approach provides a robust sample that can be used for diagnostic analysis, potentially increasing the sensitivity and reliability of CyPath® Lung in detecting early-stage lung cancer.
Bronchoscopy is a widely performed procedure in the United States, with approximately 500,000 procedures conducted annually. The market for bronchoscopy, including devices and related technologies, is valued between $700 million and $920 million, and it continues to grow. This growth is driven by the increasing prevalence of lung diseases, including chronic obstructive pulmonary disease (COPD) and lung cancer, along with the adoption of innovative diagnostic tools such as AI-enabled technologies. By exploring the use of bronchoscopy-collected samples, the CyPath® Lung study with BAMC could enhance the clinical value of these procedures and support earlier detection of lung cancer in patients at risk.
Collaboration with a Leading Medical Center
BAMC is recognized as a leader in medical research, offering access to a diverse patient population that spans the full spectrum of pulmonary health. This partnership provides an ideal environment to test and validate new diagnostic approaches. Maria Zannes, President and CEO of bioAffinity Technologies, emphasized the significance of this collaboration: “BAMC is a leader in medical research with access to a large patient population representing the full range of pulmonary health. 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.”
Advancing AI-Driven Diagnostics in Lung Cancer
The CyPath® Lung test combines advanced artificial intelligence with proprietary biomarker analysis to evaluate sputum samples for early indicators of lung cancer. Unlike traditional diagnostic methods, which often require invasive tissue biopsies, CyPath® Lung offers a noninvasive alternative that can complement existing procedures. By leveraging AI, the test can detect subtle cellular changes that may indicate early malignancy, giving physicians a powerful tool to make informed clinical decisions.
The integration of CyPath® Lung with bronchoscopy and deep suctioning samples could significantly improve the diagnostic workflow for patients with pulmonary nodules. Currently, patients often undergo multiple imaging studies and invasive procedures to confirm a diagnosis. With CyPath® Lung, clinicians may be able to obtain actionable insights earlier, potentially reducing the need for additional invasive interventions and facilitating more timely treatment decisions.
