bioAffinity Technologies to Add Mexican Patent to its CyPath Lung Technology IP

bioAffinity Technologies Inc. has received a notification of allowance from the Mexican Institute of Industrial Property for a patent application related to methods for predicting lung cancer likelihood using flow cytometry.

Upon issuance, the Mexican patent application will protect the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in sputum.

“This patent expands our global intellectual property portfolio and protection of CyPath Lung’s proprietary approach to detecting lung cancer at its earliest and most treatable stages,” bioAffinity Technologies President/CEO Maria Zannes said. “The integration of advanced cell biology, flow cytometry, and AI into an easy-to-use, noninvasive test clearly differentiates our technology, which is designed to support clinicians in evaluating indeterminate pulmonary nodules and high-risk patients.”

The company’s CyPath Lung uses flow cytometry and artificial intelligence (AI) with at-home sample collection to assess indeterminate pulmonary nodules in high-risk patients. Physicians are adding CyPath Lung to the clinical pathway to help risk stratify patients, reduce patient anxiety, support surgical and treatment decision-making, and reduce overall healthcare costs.

Executives claim the patent further strengthens the company’s intellectual property (IP) portfolio supporting its flow cytometry-based CyPath Lung diagnostic platform, which now includes multiple patents in the United States, the European Union, China, Japan, Australia, Canada and Mexico. “Strong intellectual property protection for CyPath Lung benefits not only patients and their physicians, but also supports value creation for our shareholders,” Zannes concluded.

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 AI to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy, and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

bioAffinity Technologies Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. CyPath Lung is a noninvasive test that is marketed as an LDT by Precision Pathology Laboratory Services, a bioAffinity Technologies subsidiary.