bioAffinity Technologies Secures Hong Kong Patent for CyPath® Lung Cancer Diagnostic, Bolstering Asian Market Entry

bioAffinity Technologies, Inc., a biotechnology firm specializing in noninvasive solutions for early lung disease detection, announced that the Hong Kong Intellectual Property Department has granted a patent for its proprietary CyPath® Lung technology. This patent protects the company’s platform that predicts lung cancer likelihood by using flow cytometry and fluorescent markers to analyze cell populations in sputum samples.

Maria Zannes, President and CEO of bioAffinity Technologies, emphasized the strategic importance of this patent. She stated, "The grant of this patent in Hong Kong and the 2025 patent we received from China strengthen the intellectual property protection for our technology in Asia, a region with a substantial burden of lung cancer."

Asia faces an estimated 1.6 million new lung cancer diagnoses annually, making it a critical market for early detection technologies. CyPath® Lung offers a noninvasive approach that supports earlier diagnosis and informed clinical decisions, potentially improving patient outcomes.

The newly granted Hong Kong Patent No. HK40048460, titled "System and Method for Determining Lung Health," covers the use of specific antibodies and the porphyrin TCPP to label sputum cell populations. It also claims the application of flow cytometry to detect lung cancer cells within sputum. This patented technology underpins CyPath® Lung, which is central to bioAffinity’s commercial efforts. The test aids physicians in assessing malignancy likelihood in lung nodules identified through low-dose CT scans or incidental imaging.

This Hong Kong patent complements bioAffinity’s growing global patent portfolio, which includes multiple patents and pending applications across the United States, Australia, Canada, China, the European Union, Japan, Mexico, and Singapore. Collectively, these patents protect the core technology powering CyPath® Lung and other diagnostic products in development.

CyPath® Lung is designed as a noninvasive test to enhance early lung cancer detection in high-risk patients. It employs advanced flow cytometry combined with proprietary artificial intelligence to identify malignant cell populations in sputum. The test incorporates a fluorescent porphyrin preferentially absorbed by cancerous and cancer-related cells.

In a published clinical trial involving high-risk patients with small indeterminate lung nodules under 20 millimeters, CyPath® Lung demonstrated a sensitivity of 92%, specificity of 87%, accuracy of 88%, and a negative predictive value (NPV) of 99%. These results pertain to detection use and have not been separately validated for post-treatment surveillance. The high NPV may assist physicians in deciding whether invasive procedures are necessary. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is intended to be used alongside other clinical findings rather than as a sole diagnostic tool.

bioAffinity Technologies focuses on addressing the need for noninvasive diagnostics for early-stage lung cancer and other pulmonary diseases, as well as broad-spectrum cancer treatments. CyPath® Lung, the company’s inaugural product, has shown promising clinical performance and is marketed through its subsidiary, Precision Pathology Laboratory Services. LDTs like CyPath® Lung operate under the Clinical Laboratory Improvement Amendments (CLIA), regulated by the Centers for Medicare & Medicaid Services.

The company cautions that certain statements in its announcement are forward-looking and subject to risks and uncertainties that could cause actual results to differ materially. These include challenges in commercializing CyPath® Lung domestically and internationally, maintaining patent protection, regulatory approvals, and market assumptions. Further details are available in bioAffinity’s SEC filings.

The lung cancer incidence data referenced in the announcement derive from the International Agency for Research on Cancer (IARC), World Health Organization’s Global Cancer Observatory, GLOBOCAN 2022 Lung Cancer Fact Sheet.