On September 17, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, reported that the Hong Kong Intellectual Property Department has granted a patent for the Company’s proprietary platform technology for predicting the likelihood of lung cancer using flow cytometry and fluorescent markers to characterize cell populations in sputum.
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"The grant of this patent in Hong Kong and the 2025 patent we received from China strengthen the intellectual property protection for our technology in Asia, a region with a substantial burden of lung cancer," said Maria Zannes, President and CEO of bioAffinity Technologies. "With an estimated 1.6 million new lung cancer cases diagnosed annually across Asia,1 the region represents a significant potential market for noninvasive technologies like CyPath Lung that support earlier detection and more informed clinical decision-making that can lead to better patient outcomes."
Hong Kong Patent No. HK40048460, titled "System and Method for Determining Lung Health," covers, as described in the patent claims, the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum. The patented technology is the scientific foundation underlying CyPath Lung, which remains the centerpiece of the Company’s commercial efforts, providing physicians with a noninvasive tool to assess the likelihood of malignancy in lung nodules detected by low-dose CT scans and incidental imaging.
The Hong Kong patent complements bioAffinity’s expanding global patent estate, which now covers multiple patents and pending applications in the United States and other international jurisdictions, including Australia, Canada, China, the European Union, Japan, Mexico and Singapore. Together, these patents safeguard the core technology that powers the CyPath Lung test and other diagnostics in the Company’s pipeline.
About CyPath Lung
CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. These clinical performance data relate to CyPath Lung’s use in the detection setting and have not been separately validated for post-treatment surveillance. The high NPV may help inform physician decision-making when evaluating whether further invasive procedures are warranted. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
(Press release, BioAffinity Technologies, SEP 17, 2026, View Source [SID1234670921])