bioAffinity Technologies has strengthened its global intellectual property portfolio with patent approvals in China and Canada for its CyPath Lung diagnostic platform, a noninvasive test that uses flow cytometry analysis of sputum to detect early-stage lung cancer. The biotechnology company's flagship diagnostic has demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in clinical studies.
Patent Approvals Expand Global Reach
The China National Intellectual Property Administration (CNIPA) awarded bioAffinity Technologies a patent for methods of predicting the likelihood of lung cancer using flow cytometry. Similarly, the Canadian Patent Office allowed the company's patent (Patent No. 3,136,245) titled "System and Method for Determining Lung Health."
Both patents protect the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum, along with the use of flow cytometry to determine the presence of lung cancer cells in the sputum.
"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. "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."
Significant Market Opportunities
China represents a substantial prospective market for CyPath Lung, with more than 300 million people who smoke, representing one-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.
In Canada, lung cancer is the leading cause of cancer death, with approximately 31,000 Canadians diagnosed with lung cancer in 2024 and approximately 20,700 deaths from the disease. More than 70% of lung cancer deaths were linked to smoking, according to the Canadian Cancer Society.
"Recent case studies highlight CyPath Lung's ability to detect lung cancer at its earliest stages, making our test all the more valuable in Canada where 50% of all lung cancer cases are diagnosed late at Stage IV with the five-year survival rate overall of about 19% in Canada," Zannes noted.
Clinical Performance and Technology
CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence to identify cell populations in patient sputum that indicate malignancy. The test incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells, with automated data analysis helping determine if cancer is present or if the patient is cancer-free.
Clinical study results demonstrated that CyPath Lung detected all forms of lung cancer and 80% of cancers that were Stage 1 in patients at high risk for the disease who had small lung nodules less than 20 millimeters. The test achieved 92% sensitivity, 87% specificity, and 88% accuracy in these clinical studies.
Expanding Patent Portfolio
The newly allowed patents complement bioAffinity's expanding global patent estate, which now includes multiple patents in the United States, China, Japan, Australia, Mexico, Canada, and the European Union. CyPath Lung is currently marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.
The company addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung, with CyPath Lung representing its first commercial product focused on improving outcomes through early detection and treatment of lung cancer.
