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bioAffinity Technologies Announces Grant of Hong Kong Patent for Company's CyPath® Lung Noninvasive Lung Cancer Diagnostic

  • bioAffinity Technologies announced that the Hong Kong Intellectual Property Department granted Patent No. HK40048460 for its proprietary CyPath Lung technology.
  • The granted Hong Kong patent strengthens intellectual property protection alongside a 2025 patent received from China to support entry into the Asian market.
  • The patent covers a system using defined antibodies & the porphyrin TCPP to label cell populations in sputum, utilizing flow cytometry to detect lung cancer cells.
  • Asia accounts for nearly two-thirds of global lung cancer cases, with an estimated 1.6 million new diagnoses annually.
  • CyPath Lung is a noninvasive Laboratory Developed Test (LDT) that uses flow cytometry & artificial intelligence to assess malignancy likelihood in lung nodules detected by low-dose CT scans.
  • Clinical trial data for high-risk patients showed 92% sensitivity, 87% specificity, 88% accuracy, & 99% negative predictive value for detecting lung cancer in nodules under 20 millimeters.
  • The technology is marketed as an LDT overseen under CLIA regulations by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.
  • The company's global patent estate now includes multiple patents & pending applications in the US, Australia, Canada, China, the EU, Japan, Mexico, & Singapore.