bioAffinity Technologies, Inc. (Nasdaq: BIAF) announced on October 8, 2026, that the Japan Patent Office has issued a Notice of Allowance. This notification indicates the agency's intention to grant a patent to the company for a method of predicting the likelihood of lung cancer powered by the CyPath Lung test. The patent application, titled "Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning," will be the first awarded in Japan for the CyPath Lung test driven by an AI-built algorithm.
According to the company, this patent will be the fifth awarded in Asia to protect its early lung cancer test, following grants in China and Hong Kong. The patent strengthens the company's intellectual property portfolio, which currently includes 22 awarded U.S. and foreign patents and 36 pending patent applications related to its diagnostic platform and cancer treatment therapeutics.
The CyPath Lung test is a noninvasive diagnostic tool designed to assess indeterminate pulmonary nodules in high-risk patients. It utilizes flow cytometry and artificial intelligence to analyze patient sputum. In a published clinical trial involving high-risk patients with small nodules less than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy, and a 99% negative predictive value. The patent is expected to be issued following the payment of applicable fees.
