bioAffinity Technologies receives Japanese patent notice for CyPath Lung

bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) announced that the Japan Patent Office has issued a Notice of Allowance indicating its intention to grant a patent for the company's CyPath® Lung test, a noninvasive lung cancer detection method that uses flow cytometry and artificial intelligence.

The Japanese patent application, titled "Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning," would be the first patent awarded in Japan for CyPath Lung driven by an AI-built algorithm. It would also be the fifth patent protecting the test in Asia, following patents in China and Hong Kong.

The addition would expand bioAffinity Technologies' 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. Final issuance of the Japanese patent is expected after payment of the applicable issuance fee.

CyPath Lung analyzes patient sputum collected at home using flow cytometry and proprietary AI to assess indeterminate pulmonary nodules in patients at high risk for lung cancer. In a published clinical trial, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy, and a 99% negative predictive value in patients with small indeterminate lung nodules under 20 millimeters.

"The Japanese patent for the CyPath Lung test strengthens and expands the Company's intellectual property protection in the Asian market," said Maria Zannes, President and CEO of bioAffinity Technologies. "We anticipate patents in additional geographic regions will follow."

CyPath Lung is marketed as a Laboratory Developed Test by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies, and is not intended for use as a sole diagnostic tool.

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