bioAffinity Technologies, Inc. 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 for early-stage lung cancer.
The patent application, titled "Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning," is the first awarded in Japan for the CyPath Lung test driven by an AI-built algorithm. It marks the fifth patent protecting the company's early lung cancer test awarded in Asia, following patents in China and Hong Kong.
The CyPath Lung test is a noninvasive diagnostic tool designed to improve the early detection of lung cancer in high-risk patients. It utilizes flow cytometry and proprietary artificial intelligence to identify cell populations in patient sputum that indicate malignancy. The test incorporates a novel fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells.
According to a published clinical trial involving high-risk patients with small indeterminate lung nodules less than 20 millimeters, CyPath Lung demonstrated the following performance metrics: 92% sensitivity, 87% specificity, 88% accuracy, and 99% negative predictive value (NPV). The high NPV is intended to help physicians make decisions regarding further invasive procedures.
The company’s total intellectual property portfolio currently includes 22 awarded U.S. and foreign patents and 36 pending patent applications related to its diagnostic platform and cancer treatment therapeutics. Issuance of the Japanese patent is expected to occur after the payment of the applicable issuance fee.
