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bioAffinity Technologies Announces Notification of Japanese Patent Allowance Covering Noninvasive CyPath® Lung and AI-Built Algorithm

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  • bioAffinity Technologies, Inc. received a Notice of Allowance from the Japan Patent Office for its CyPath Lung AI-powered lung cancer prediction method.
  • The patent titled "Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry & Machine Learning" will be the first awarded in Japan for this specific AI-driven approach.
  • This grant marks the fifth patent protecting the early lung cancer test in Asia, following awards in China & Hong Kong.
  • The company now holds 22 awarded U.S. & foreign patents with 36 pending applications related to its diagnostic platform & therapeutics.
  • CyPath Lung is a noninvasive test using flow cytometry & AI to assess indeterminate pulmonary nodules in high-risk patients via at-home sputum collection.
  • Clinical trials showed 92% sensitivity, 87% specificity, 88% accuracy, & 99% negative predictive value for detecting lung cancer in patients with nodules under 20 millimeters.
  • The test utilizes a novel fluorescent porphyrin preferentially taken up by cancer cells to identify malignancy in sputum samples.
  • CyPath Lung is marketed as a Laboratory Developed Test (LDT) overseen under CLIA regulations & is intended to support, not replace, physician decision-making.
  • The patent issuance is expected to occur after the payment of applicable fees, with further geographic patents anticipated.