BioAffinity Technologies Receives China Patent for Its Noninvasive Lung Cancer Diagnostic Tool
A biotechnology company advancing early-stage cancer diagnostics including CyPath® Lung, the Company’s commercially available test for early-stage lung cancer, today announced it has received notification of allowance from the China National Intellectual Property Administration (CNIPA) for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry.
With lung cancer representing a major health burden globally and particularly in China, securing this intellectual property positions us well for future opportunities in one of the world’s largest and most underserved healthcare markets.
China represents a large prospective market for CyPath® Lung with more than 300 million people who smoke, or a third of the world’s total smokers, according to the World Health Organization. The China cancer registry estimated 1.06 million new cases of lung cancer were diagnosed in 2022.
“This patent is another step forward in our strategy to safeguard and expand the reach of our proprietary diagnostic platform internationally,” said Maria Zannes, President and CEO of bioAffinity Technologies. “With lung cancer representing a major health burden globally and particularly in China, securing this intellectual property positions us well for future opportunities in one of the world’s largest and most underserved healthcare markets. It reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives.”
The newly allowed Chinese patent—titled “System and Method for Determining Lung Health”—protects 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.
CyPath® Lung is the Company’s first commercial product, with clinical study results demonstrating 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. In the study, CyPath® Lung detected all forms of lung cancer and 80% of cancers that were Stage 1.
This newly allowed patent complements bioAffinity’s expanding global patent estate, which now includes multiple patents in the U.S, China, Japan, Australia, Mexico, Canada and the EU.
About CyPath® Lung
CyPath® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies
