bioAffinity Technologies (NASDAQ: BIAF; BIAFW) has initiated a 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 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.
In a statement, Gordon Downie, MD, PhD, CMO of bioAffinity, commented, “As more indeterminate pulmonary nodules are found either incidentally or by routine lung cancer screening, CyPath Lung can fill the diagnostic gap between ‘watchful waiting’ and invasive procedures that carry risk. As a result, we see growing adoption and use of CyPath Lung by physicians and expect this longitudinal trial to provide additional evidence to support inclusion of our noninvasive test as part of the standard of care for lung cancer screening and diagnosis.”
Maria Zannes, president and CEO of bioAffinity, added, “Initiating this study represents an important milestone for CyPath Lung. By following patients longitudinally across multiple sites, we expect to acquire robust, real-world data that reflects how CyPath Lung may be used to support risk assessment and clinical decision-making aligned with our objective to establish CyPath Lung as a standard of care for evaluating patients at high-risk for early-stage lung cancer.”
