bioAffinity receives Australian patent acceptance for lung disease test

SAN ANTONIO - bioAffinity Technologies, Inc. (Nasdaq:BIAF; BIAFW), a microcap biotech company with a current market value of $11.63 million, announced Tuesday that the Australian Patent Office has accepted a patent application for its technology that assesses lung health and predicts the likelihood of multiple lung diseases. According to InvestingPro analysis, the company’s stock appears undervalued despite facing significant operational challenges.

The patent application, titled "System and Method for Determining Lung Health," covers methods using flow cytometry combined with fluorescent probes to detect cellular and molecular signatures of various lung diseases in sputum samples.

"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, in a press release statement.

The Australian patent will automatically be issued three months after the acceptance date unless a third party files a successful opposition. This addition complements bioAffinity’s existing intellectual property protection across multiple international jurisdictions, including the United States.

According to the company, its current patent portfolio includes 18 awarded and 33 pending patents across countries including the U.S., Canada, China, France, Germany, Hong Kong, Italy, Japan, Mexico, Spain, Sweden and the United Kingdom.

bioAffinity’s flagship product, CyPath Lung, is a noninvasive test for lung cancer that uses proprietary flow cytometry and artificial intelligence to identify cell populations in patient sputum that may indicate malignancy. The company reports that clinical study results showed the test achieved 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules.

The test is currently marketed as a Laboratory Developed Test by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.

In other recent news, bioAffinity Technologies has successfully raised $1.8 million through a registered direct offering. The company sold 720,000 shares of common stock at $2.50 per share, with WallachBeth Capital, LLC acting as the sole placement agent for the transaction. Additionally, bioAffinity Technologies has regained compliance with Nasdaq’s continued listing requirements. The company met the minimum closing bid price of $1.00 per share and the minimum stockholders’ equity requirement of $2.5 million. Furthermore, bioAffinity Technologies received a patent allowance from the United States Patent and Trademark Office for its AI-built algorithm and flow cytometry platform for lung cancer detection. This new patent covers a system and method for predicting lung cancer likelihood by analyzing patient sputum samples. These developments are part of bioAffinity Technologies’ ongoing efforts in the biotechnology sector.

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