Sputum-Based Lung Cancer Test Technology Granted Hong Kong Patent

6 million new diagnoses across the region each year. Against this substantial disease burden, a newly granted patent covers a sputum-based flow cytometry method that uses fluorescent markers to characterize cell populations and estimate the likelihood of lung cancer.

bioAffinity Technologies’ (San Antonio, TX, USA) CyPath Lung is a noninvasive test based on the company’s proprietary platform for assessing lung cancer risk. The Hong Kong Intellectual Property Department has granted a patent covering the use of flow cytometry and fluorescent markers to characterize cell populations in sputum and predict the likelihood of lung cancer. The patent complements a 2025 grant in China and expands the company’s broader patent portfolio in the United States to other international markets.

CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. The noninvasive test is designed to help physicians assess the likelihood of malignancy in lung nodules identified through low-dose computed tomography (CT) or incidental imaging. Marketed as a Laboratory Developed Test (LDT), it is not intended to serve as a standalone diagnostic and should be interpreted alongside other clinical findings.

In a published clinical trial involving high-risk patients with small indeterminate lung nodules measuring less than 20 millimeters, CyPath Lung achieved 92% sensitivity, 87% specificity, 88% accuracy, and a 99% negative predictive value for lung cancer detection. These performance data apply to detection and have not been separately validated for post-treatment surveillance. The high negative predictive value may help clinicians determine whether additional invasive diagnostic procedures are warranted.

“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. 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,” said Maria Zannes, President and CEO of bioAffinity Technologies.

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