bioAffinity Technologies, Inc. (NASDAQ: BIAF) has had its Australian patent application (AU 2019253111) accepted by the Australian Patent Office. The application, titled “System and Method for Determining Lung Health,” covers a flow‑cytometry platform that uses fluorescent probes to detect cellular and molecular signatures of multiple lung diseases in sputum samples.
The acceptance is the first step toward automatic issuance, which will occur three months after the acceptance date unless a third party files an opposition. The new patent expands the company’s Australian portfolio and complements existing U.S., Canadian, European, and other international patents, including a prior Australian acceptance on January 22, 2025 for an early‑stage lung‑cancer detection platform.
bioAffinity’s flagship product, CyPath Lung, is marketed as a laboratory‑developed test by its Precision Pathology Laboratory Services subsidiary. Clinical studies reported 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high‑risk patients with small nodules under 20 mm.
The company’s global patent estate now includes 18 awarded and 33 pending patents across 13 countries. Despite the strategic value of the new patent, bioAffinity remains a microcap firm with a market capitalization around $11–12 million and faces negative operating margins and limited financial strength.
The new patent positions bioAffinity to broaden the market reach of CyPath Lung and support future product extensions, reinforcing its competitive moat in the early‑stage lung‑cancer diagnostic market.
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