bioAffinity Technologies receives US patent allowance for lung cancer test

bioAffinity Technologies, Inc. (NASDAQ: BIAF) received notification of allowance from the United States Patent and Trademark Office for a patent covering its artificial intelligence algorithm and flow cytometry platform used to detect lung cancer through sputum analysis.

The patent, titled "Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning," covers a system and method for predicting lung cancer likelihood by analyzing patient sputum samples. The technology is incorporated into the company's CyPath Lung test, which is commercially available as a laboratory developed test.

The CyPath Lung test uses flow cytometry to detect changes in the lung linked to cancer, including populations of immune cells, apoptotic cells and cancer-related cells labeled with the company's TCPP porphyrin. The AI-driven analysis combines these variables with patient age to predict cancer presence.

According to clinical study results referenced by the company, CyPath Lung 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 newly allowed US patent adds to bioAffinity's patent portfolio, which now includes 18 awarded and 33 pending patents across multiple countries including the United States, Canada, China, France, Germany, Hong Kong, Italy, Japan, Mexico, Spain, Sweden, and the United Kingdom.

CyPath Lung is marketed as a laboratory developed test by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. The test is designed to help physicians determine next steps for patients with pulmonary nodules requiring follow-up.

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