bioAffinity Technologies Announces Notification of Mexico Patent Allowance Covering Novel Lung Cancer Detection Methods Using CyPath® Lung Technology

Key Terms

flow cytometry medical

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.

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.

tcpp medical

TCPP (tris(1‑chloro‑2‑propyl) phosphate) is a widely used flame retardant and plasticizer added to foam, textiles and plastics to reduce flammability—think of it as a chemical “fireproofing” treatment mixed into materials. Investors watch TCPP because regulatory limits, safety concerns, or shifts to alternative materials can affect manufacturers’ costs, product demand, liability exposure and supply chains, potentially changing earnings or valuation.

artificial intelligence technical

Artificial intelligence is the ability of computers and machines to perform tasks that typically require human thinking, such as understanding language, recognizing patterns, or making decisions. For investors, it matters because AI can enhance efficiency, uncover new insights, and enable smarter strategies, potentially impacting the value and performance of companies that develop or utilize this technology.

sputum medical

Sputum is the mucus and material coughed up from the lungs and airways, collected as a sample for laboratory testing. For investors, sputum matters because it is a primary clinical specimen used to diagnose respiratory infections, measure drug or vaccine effectiveness, and support regulatory evidence; the ease of collecting reliable sputum samples can affect trial outcomes, market acceptance of diagnostics and therapies, and commercial potential in respiratory health.

pulmonary nodules medical

Pulmonary nodules are small, round or oval spots found in the lungs on X-rays or CT scans; they can be scar tissue, infections, or early tumors. For investors, these findings matter because they can trigger diagnostic follow-up, treatment decisions, drug or device demand, clinical trial activity, regulatory scrutiny, and potential changes in healthcare costs or company valuations—think of a nodule like a small warning light that may or may not signal a serious engine problem.

noninvasive medical

Noninvasive describes medical tests, devices, or procedures that do not break the skin or enter the body, working from outside the body such as scans, external sensors, or topical treatments. For investors, noninvasive options often mean lower development and regulatory hurdles, faster adoption, and broader market appeal because patients and providers prefer less discomfort and simpler logistics—similar to using a forehead thermometer instead of a blood draw—which can reduce costs and speed revenue.

diagnostic platform medical

A diagnostic platform is a combined set of instruments, software and test methods that together run medical tests to detect disease, infections, or biological markers. Investors care because its accuracy, speed, and ability to run many different tests determine how widely it can be adopted, how much recurring revenue it can generate, and how easily it can scale—similar to a smartphone that gains value by running many useful apps reliably.

Strong intellectual property portfolio helps build shareholder value

Patent strategy protects CyPath^® Lung’s flow cytometry-driven diagnostic approach in international markets

SAN ANTONIO--(BUSINESS WIRE)-- bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath^® Lung, the Company’s commercially available test for early-stage lung cancer, today announced it has received notification of allowance from the Mexican Institute of Industrial Property for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry.

Upon issuance, the Mexican patent application will protect 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 sputum.

“This patent expands our global intellectual property portfolio and protection of CyPath^® Lung’s proprietary approach to detecting lung cancer at its earliest and most treatable stages,” said Maria Zannes, President and CEO of bioAffinity Technologies. “The integration of advanced cell biology, flow cytometry and AI into an easy-to-use, noninvasive test clearly differentiates our technology, which is designed to support clinicians in evaluating indeterminate pulmonary nodules and high-risk patients.”

CyPath^® Lung uses flow cytometry and artificial intelligence with at-home sample collection to assess indeterminate pulmonary nodules in high-risk patients. Physicians are adding CyPath^® Lung to the clinical pathway to help risk stratify patients, reduce patient anxiety, support surgical and treatment decision-making, and reduce overall healthcare costs.

The patent further strengthens the Company’s intellectual property (IP) portfolio supporting its flow cytometry-based CyPath^® Lung diagnostic platform, which now includes multiple patents in the United States, the European Union, China, Japan, Australia, Canada and Mexico. “Strong intellectual property protection for CyPath^® Lung benefits not only patients and their physicians, but also supports value creation for our shareholders,” Ms. Zannes said.

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. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. 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), 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 risk that pending patent applications may not result in issued patents, changes in the regulatory framework governing Laboratory Developed Tests including potential increased FDA oversight, the Company's ability to successfully commercialize CyPath^® Lung in domestic and international markets, the Company's ability to realize value from its international intellectual property portfolio, the sufficiency of the Company's capital resources, and the 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260527333514/en/

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

Source: bioAffinity Technologies, Inc.