bioAffinity Technologies, Inc. (Nasdaq: BIAF) announced on September 17, 2026, that the Hong Kong Intellectual Property Department has granted a patent for the Company’s proprietary technology. The patent, titled "System and Method for Determining Lung Health" and numbered HK40048460, covers the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum. The technology utilizes flow cytometry to determine the presence of lung cancer cells in sputum samples.
This intellectual property grant is intended to support the commercialization of CyPath Lung, the Company’s noninvasive diagnostic test. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is designed to assess the likelihood of malignancy in lung nodules detected by low-dose CT scans. The test uses advanced flow cytometry and proprietary artificial intelligence to identify cell populations in patient sputum that indicate malignancy.
According to the filing, CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial involving high-risk patients with small indeterminate lung nodules less than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy, and a 99% negative predictive value (NPV).
The Company noted that the Hong Kong patent complements its existing global patent estate, which includes patents and pending applications in the United States, Australia, Canada, China, the European Union, Japan, Mexico, and Singapore. The filing referenced data from the International Agency for Research on Cancer (IARC) indicating that Asia accounts for nearly two-thirds of lung cancer cases worldwide, with an estimated 1.6 million new cases diagnosed annually in the region.
