bioAffinity Technologies Announces Acceptance of Australian Patent Application for Platform to Detect and Characterize Multiple Lung Diseases

bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage diagnostics including CyPath Lung, the Company’s noninvasive test for lung cancer, today announced that the Australian Patent Office (IP Australia) has accepted a patent application for the Company’s proprietary platform technology for assessing lung health and predicting the likelihood of multiple lung diseases in patients.

“This accepted patent application underscores the broad potential of our technology to improve the diagnosis and management of lung disease,” said Maria Zannes, President and CEO of bioAffinity Technologies. “The invention behind this patent uses our flow cytometry platform to reveal disease-related changes across multiple cell types in a sputum sample. We believe this innovation can lead to a new generation of diagnostic tools for personalized lung health.”

Australia patent application AU 2019253111, titled “System and Method for Determining Lung Health,” covers methods that use flow cytometry combined with fluorescent probes, molecular “tags” that attach to specific cell types, to detect cellular and molecular signatures of multiple lung diseases.

bioAffinity’s flagship product, CyPath Lung, remains the centerpiece of the Company’s commercial efforts, providing physicians with a noninvasive tool to assess lung nodules detected by low-dose CT scans and incidental imaging.

The Australian patent complements bioAffinity’s existing intellectual property protection in the United States and other international jurisdictions. Together, these patents safeguard the core technology that powers the CyPath Lung test and other diagnostics in the Company’s pipeline.

The Australia patent will be automatically issued three months after the acceptance date unless a third party files an opposition and proves to IP Australia why the patent should not be issued. Until then, bioAffinity’s expanding global patent estate includes 18 awarded and 33 pending patents. The Company holds patents in the U.S., Australia, Canada, China, France, Germany, Hong Kong, Italy, Japan, Mexico, Spain, Sweden and the United Kingdom.

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.