bioAffinity Technologies Adds Japanese Patent to its IP Portfolio

Japan’s Patent Office has awarded a patent to bioAffinity Technologies Inc. for its method of predicting the likelihood of lung cancer using the CyPath Lung diagnostic test.

The patent, “System and Method for Determining the State of Health of the Lungs,” adds to bioAffinity Technologies’ overall patent portfolio, which includes 17 awarded U.S. and foreign patents and 30 pending applications related to its diagnostic platform and cancer treatment therapeutics. The Japanese patent is the first awarded for the CyPath Lung flow cytometry test as a stand-alone assay for lung cancer detection.

“The Japanese patent for CyPath Lung is a significant step forward in extending protection for the intellectual property behind our noninvasive test for early-stage lung cancer. We anticipate patents in additional geographic regions will follow,” bioAffinity Technologies President/CEO Maria Zannes said. “Lung cancer is the deadliest cancer worldwide. We believe CyPath Lung has the potential to improve the outcome for lung cancer patients around the globe through earlier detection when treatment options are better. Strong intellectual property protection for CyPath Lung benefits not only patients and their physicians, but also our shareholders and our company. Our scientific team continues research and development on diagnostics that will open new markets for bioAffinity Technologies.”

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival.

bioAffinity Technologies Inc. addresses the need for noninvasively diagnosing early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The company’s first product, CyPath Lung, is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.