DENVER, Colo. (247marketnews.com) -- bioAffinity Technologies (NASDAQ:BIAF) is expanding the intellectual-property moat around its CyPath Lung diagnostic, adding a newly granted Hong Kong patent to a patent covering the technology in China. The move gives the company dual patent protection in two important Asian markets as it looks to expand the commercial potential of a noninvasive approach to lung-cancer detection.
The announcement arrives against a formidable backdrop: Asia carries a substantial share of the global lung-cancer burden, creating a potentially significant market for technologies designed to help identify malignancy without immediately resorting to invasive procedures.
The newly granted Hong Kong Patent No. HK40048460, titled “System and Method for Determining Lung Health,” covers technology using defined antibodies and the fluorescent porphyrin TCPP to label cell populations in sputum, followed by flow cytometry to assess the presence of lung-cancer cells. bioAffinity says the Hong Kong protection complements a China patent granted in 2025 and a broader international portfolio spanning the United States, Australia, Canada, the European Union, Japan, Mexico and Singapore.
“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,” said Maria Zannes, President and CEO of bioAffinity Technologies.
The commercial thesis centers on CyPath Lung, a Laboratory Developed Test marketed by Precision Pathology Laboratory Services, a bioAffinity subsidiary. The test is designed to help physicians assess the likelihood of malignancy in lung nodules identified through low-dose CT scans or incidental imaging. It analyzes sputum using flow cytometry and a proprietary fluorescent porphyrin that is preferentially taken up by cancer and cancer-associated cells.
The company is pointing to previously published clinical data as evidence of the test's potential. In a study of high-risk patients with small, indeterminate lung nodules, CyPath Lung reported 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value. Those figures come from the company's cited clinical trial and apply to the detection setting; they have not been separately validated for post-treatment surveillance.
CyPath Lung is not intended to be used as a standalone diagnostic, and its results are intended to be considered alongside other clinical findings.
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