BIAF News & Events

bioAffinity Technologies announced that unit sales for its CyPath Lung diagnostic in the first quarter of 2026 exceeded internal projections and, based on preliminary unaudited data, achieved 146% growth compared to the first quarter of 2025, reflecting accelerating physician adoption and expanding clinical use of the Company's noninvasive lung cancer diagnostic test. "The stronger than expected unit growth in the first quarter of 2026 reflects growing recognition of the value that CyPath(R) Lung brings to clinical decision-making and patient outcomes," said Maria Zannes, President and CEO of bioAffinity Technologies. "Physicians are seeking more accurate, noninvasive tools to assess lung cancer risk and detect disease at its earliest, most treatable stage. CyPath(R) Lung is designed to address a critical gap in the diagnostic pathway by supporting lung cancer risk assessment, pulmonary nodule management and post-treatment surveillance. Our growing body of evidence - including real-world case studies - further supports CyPath(R) Lung's potential clinical utility."

BioAffinity Technologies announced initiation of the company's planned large-scale, longitudinal clinical study for CyPath Lung, its noninvasive diagnostic test for the detection of 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 the presence of lung cancer in high-risk individuals with existing lung nodules six millimeters to less than 30 mm in diameter identified by lung cancer screening. BioAffinity Technologies expects up to 20 clinical study sites, including a dozen Department of Veterans Affairs (VA) medical centers and two of the nation's largest military hospitals, will participate in the study. The longitudinal clinical trial announced today will evaluate FlowPath Lung, a research-use test that uses the same technology and follows the same procedures as CyPath Lung.

BioAffinity Technologies announced a study with Brooke Army Medical Center to validate the clinical utility of using the CyPath Lung diagnostic test to assess sputum samples obtained by tracheal and bronchial suctioning for early detection of lung cancer. "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," said Gordon Downie, chief medical officer of BioAffinity Technologies.

bioAffinity Technologies released a new clinical case study in which its CyPath Lung noninvasive diagnostic test for lung cancer helped determine the appropriate treatment for a 79-year-old female with a suspicious lung finding on a low-dose computed tomography scan. The patient, a current smoker with a medical history significant for chronic obstructive pulmonary disease and coronary heart disease, underwent LDCT screening in June 2025. Imaging revealed a spiculated, or irregularly shaped, nodule about half an inch in size at the bottom of the right lung, near the lining of the lung. Spiculated nodules raise concerns about malignancy due to their uneven, irregular appearance. The CyPath Lung test result was negative, indicating an unlikely malignancy in the lung and supporting a conservative management approach that includes annual CT screening. A repeat scan in October 2025 showed that the suspicious finding from the June scan had resolved, and there were no pulmonary nodules in the lungs.