bioAffinity Technologies Announces Grant of Hong Kong Patent for Company's CyPath® Lung Noninvasive Lung Cancer Diagnostic

The new Hong Kong patent extends bioAffinity Technologies’ CyPath Lung IP coverage in Asia, reinforcing its position in a large lung cancer market.

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Dual patent protection in Hong Kong and China strengthens CyPath Lung’s positioning to enter Asian market

Asia accounts for nearly two-thirds of lung cancer cases worldwide

SAN ANTONIO--(BUSINESS WIRE)-- bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, today announced that the Hong Kong Intellectual Property Department has granted a patent for the Company’s proprietary platform technology for predicting the likelihood of lung cancer using flow cytometry and fluorescent markers to characterize cell populations in sputum.

"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," said Maria Zannes, President and CEO of bioAffinity Technologies. "With an estimated 1.6 million new lung cancer cases diagnosed annually across Asia,¹ the region represents a significant potential market for noninvasive technologies like CyPath® Lung that support earlier detection and more informed clinical decision-making that can lead to better patient outcomes."

Hong Kong Patent No. HK40048460, titled "System and Method for Determining Lung Health," covers, as described in the patent claims, the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum. The patented technology is the scientific foundation underlying CyPath Lung, which remains the centerpiece of the Company's commercial efforts, providing physicians with a noninvasive tool to assess the likelihood of malignancy in lung nodules detected by low-dose CT scans and incidental imaging.

The Hong Kong patent complements bioAffinity’s expanding global patent estate, which now covers multiple patents and pending applications in the United States and other international jurisdictions, including Australia, Canada, China, the European Union, Japan, Mexico and Singapore. Together, these patents safeguard the core technology that powers the CyPath Lung test and other diagnostics in the Company’s pipeline.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. These clinical performance data relate to CyPath Lung's use in the detection setting and have not been separately validated for post-treatment surveillance. The high NPV may help inform physician decision-making when evaluating whether further invasive procedures are warranted. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

About bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to successfully commercialize CyPath® Lung or other diagnostic products in the United States or internationally; the Company’s ability to obtain and maintain patent protection and defend its intellectual property rights in the United States and foreign jurisdictions; uncertainties regarding the enforceability of patents in foreign jurisdictions, including Hong Kong and China; the Company’s ability to obtain regulatory approvals or clearances required to market its products in international markets; the accuracy of third-party estimates of market size and lung cancer incidence; the Company’s need for additional capital and its ability to obtain financing on acceptable terms; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

¹ Source: International Agency for Research on Cancer (IARC), World Health Organization, Global Cancer Observatory, GLOBOCAN 2022: Lung Cancer Fact Sheet.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260917849195/en/

bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com

Source: bioAffinity Technologies, Inc.

Key Terms

flow cytometry technical

A laboratory method that uses lasers and sensors to count and analyze individual cells or tiny particles as they flow past a detector, like a high‑speed supermarket scanner that reads barcodes on each item. Investors care because flow cytometry is widely used in drug development, diagnostics and manufacturing quality control; demand for the instruments, reagents and services can signal progress in clinical programs, recurring revenue streams and adoption of new therapies or tests.

negative predictive value medical

Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.

laboratory developed test regulatory

A laboratory developed test is a medical diagnostic created, validated and performed within a single clinical laboratory rather than sold as a boxed product to other labs or clinics. For investors, LDTs can offer faster product rollout and niche revenue streams like a custom service, but they also carry regulatory and reimbursement uncertainty and competitive risk—think of them as a handmade tool that can be quickly offered to customers but may face shifting rules or market limits.

clia regulatory

CLIA stands for the Clinical Laboratory Improvement Amendments, a U.S. federal program that sets quality and safety standards for laboratories that test human samples. For investors, a CLIA certification is like a safety inspection or license for a lab — it signals that test results are produced under accepted quality controls, affects a lab’s ability to sell or bill certain tests, and therefore influences a company’s regulatory risk, market access, and credibility.

porphyrin medical

Porphyrins are a family of organic ring-shaped molecules that bind metals—most commonly forming heme in blood and chlorophyll in plants—acting like tiny sockets that carry oxygen or capture light. They matter to investors because porphyrin chemistry underlies diagnostic tests, certain metabolic disease markers, light-based therapies and specialty materials; discoveries or approvals involving porphyrins can affect a company’s product development, regulatory risk and market value.