The patent covers technology underlying the CyPath Lung test, including the use of flow cytometry, antibodies, and fluorescent markers to analyze sputum samples.
The Hong Kong Intellectual Property Department has granted a patent to bioAffinity Technologies for its proprietary platform technology designed to predict the likelihood of lung cancer, according to a company press release. The noninvasive diagnostic approach uses flow cytometry and fluorescent markers to characterize cell populations collected from patient sputum.
The newly issued patent, Hong Kong Patent No. HK40048460, establishes intellectual property protection alongside a patent granted to the company in China in 2025, strengthening the biotechnology firm’s position across the Asian market, where the company notes that nearly two-thirds of worldwide lung cancer cases occur.
“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,” says Maria Zannes, president and CEO of bioAffinity Technologies, in a release. “With an estimated 1.6 million new lung cancer cases diagnosed annually across Asia, 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.”
Flow Cytometry and Porphyrin Labeling Foundation
According to bioAffinity Technologies, the patented technology serves as the scientific foundation for CyPath Lung, the company’s central commercial diagnostic. The test is designed to provide physicians with a noninvasive laboratory tool to evaluate the likelihood of malignancy when lung nodules are discovered through low-dose CT scans or incidental imaging findings.
The patent claims specifically protect the use of defined antibodies and the porphyrin TCPP to label cell populations within sputum samples, followed by flow cytometric analysis to identify the presence of lung cancer cells. By profiling these cellular characteristics in sputum, the assay delivers objective diagnostic data to assist in subsequent clinical decisions.
International Patent Estate Expansion
The Hong Kong issuance adds to bioAffinity’s broader international patent portfolio, which the company states includes granted patents and pending applications in the US, Australia, Canada, China, the European Union, Japan, Mexico, and Singapore. The company reports that this intellectual property foundation protects both the CyPath Lung test and additional early detection diagnostics in its development pipeline.
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