bioAffinity Technologies receives Canadian patent for lung cancer test

bioAffinity Technologies Inc. (NASDAQ: BIAF) announced that the Canadian Patent Office has granted a patent for its CyPath Lung diagnostic test method. The patent protects the company's flow cytometry analysis technique used to detect lung disease through sputum samples.

The Canadian patent, numbered 3,136,245 and titled "System and Method for Determining Lung Health," covers the use of specific antibodies and the porphyrin TCPP to label cell populations in sputum. The patent also protects the company's use of flow cytometry to identify lung cancer cells in sputum samples.

According to the Canadian Cancer Society, lung cancer represents the leading cause of cancer death in Canada. In 2024, approximately 31,000 Canadians received lung cancer diagnoses, with about 20,700 deaths attributed to the disease. More than 70% of lung cancer deaths were linked to smoking.

CyPath Lung uses flow cytometry and artificial intelligence to analyze cell populations in patient sputum samples. The test incorporates a fluorescent porphyrin that cancer and cancer-related cells preferentially absorb. Clinical study results published in Respiratory Research demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules less than 20 millimeters.

The biotechnology company previously received a similar patent in China. CyPath Lung is marketed as a Laboratory Developed Test through Precision Pathology Laboratory Services, a bioAffinity Technologies subsidiary.

Canadian government statistics indicate that 50% of lung cancer cases are diagnosed at Stage IV, with an overall five-year survival rate of approximately 19% in Canada.

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