bioAffinity Technologies Announces Notification of Japanese Patent Allowance Covering Noninvasive CyPath® Lung and AI-Built Algorithm
bioAffinity Technologies announced that the Japan Patent Office has issued a Notice of Allowance for a patent covering its CyPath Lung method that combines automated flow cytometry and machine learning. The company described the patent as the first in Japan for CyPath Lung driven by an AI-built algorithm and highlighted prior patents and clinical performance metrics for the test.
What happened
bioAffinity Technologies reported that the Japan Patent Office issued a Notice of Allowance indicating its intention to grant a patent for a method described as predicting the likelihood of lung cancer powered by the CyPath Lung test. The company characterized the application as titled "Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning" and said this will be the first awarded patent in Japan for CyPath Lung driven by an AI-built algorithm and the fifth patent protecting the test in Asia.
Sources: S1
Company intellectual property context
In the release, bioAffinity stated its broader patent portfolio includes "22 awarded U.S. and foreign patents and 36 pending patent applications" related to its diagnostic platform and cancer therapeutics. The company framed the Japanese allowance as expanding protection in the Asian market and said it anticipates patents in additional geographic regions will follow.
Sources: S1
About CyPath Lung and reported clinical performance
bioAffinity described CyPath Lung as a noninvasive test using flow cytometry, proprietary AI, and at-home sputum collection to assess indeterminate pulmonary nodules in high-risk patients. The company reported clinical-trial performance numbers for high-risk patients with small indeterminate nodules less than 20 millimeters: "92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV)" and said the test is marketed as a Laboratory Developed Test (LDT).
Sources: S1
Why this may matter (editorial inference)
An awarded patent in Japan would add a jurisdictional layer of intellectual property protection for the CyPath Lung method as described by the company. The company argues that such patent coverage could support commercialization or licensing efforts in Asian markets and strengthen its asserted competitive position for the CyPath Lung test. This is an inference based on the company statements about patent scope and market strategy, not an independent verification.
Sources: S1
Next steps noted by the company
The company stated that issuance of the patent is expected to result after payment of the applicable issuance fee and included standard forward-looking cautionary language about risks and uncertainties related to patent issuance, enforceability, and the clinical and commercial potential of CyPath Lung.
Sources: S1
What remains uncertain
- The announcement is an issuer press release and reflects the company's characterization of the Notice of Allowance; the patent's final issuance, scope, and enforceability are not independently verified in the release.
- The release states "Issuance of the patent is expected to result after payment of the applicable issuance fee," indicating the patent is not yet granted and timing and final grant remain subject to administrative steps.
- Clinical performance statistics cited are reported by the company and relate to a published clinical trial described by the company; the press release does not provide independent verification or the full trial protocol, sample size, or statistical uncertainty measures.