bioAffinity Technologies announced a validation study with Brooke Army Medical Center (BAMC) to evaluate the use of CyPath® Lung on sputum samples obtained by tracheal and bronchial suctioning during bronchoscopy. The study will enroll approximately 30‑50 patients and is expected to deliver results by mid‑2026.
CyPath® Lung has previously demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high‑risk patients with small indeterminate lung nodules. The new study will test the technology’s performance on a broader range of sputum samples, potentially expanding its clinical utility.
BAMC, located at Joint Base San Antonio‑Fort Sam Houston, Texas, is the United States Army’s premier academic medical center and the Department of War’s largest hospital. Partnering with BAMC gives bioAffinity access to a large, diverse patient population and a respected research environment.
The bronchoscopy market is valued at $700‑$920 million annually, with roughly 500,000 procedures performed each year in the U.S. The lung cancer diagnostics market is projected to reach $4.7 billion by 2030, underscoring the strategic importance of expanding CyPath® Lung’s reach.
Financially, bioAffinity has faced significant challenges. Revenue declined 28% over the past twelve months, and the company reported a $9.04 million loss in 2024, a 13.9% increase from 2023. Despite these headwinds, CyPath® Lung testing revenue grew 86% in Q3 2025, and the number of pulmonology practices offering the test increased 139% since January 2024.
Maria Zannes, President and CEO, said, “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.” Gordon Downie, MD, PhD, Chief Medical Officer, added, “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 validation study is a key step toward broader adoption of CyPath® Lung, but bioAffinity’s financial trajectory remains a concern. Analysts maintain a “Hold” consensus rating, citing the company’s large cash burn and negative operating cash flow. The partnership with BAMC, however, could strengthen the product’s clinical evidence base and support future commercialization efforts.
The study’s outcome will be closely watched by investors and clinicians alike, as it could validate a new sample type that would make CyPath® Lung more accessible in routine bronchoscopy workflows, potentially accelerating market penetration in a rapidly growing diagnostic space.
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