bioAffinity Technologies Appoints Dr. Gordon Downie, MD, PhD, as Chief Medical Officer

By: bioAffinity Technologies, Inc. via Business Wire

May 20, 2025 at 09:00 AM EDT

bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage cancer, today announced the appointment of Gordon Downie, MD, PhD, as its new Chief Medical Officer (CMO). Dr. Downie brings more than three decades of experience in pulmonary medicine, clinical research, medical innovation, and interventional pulmonology to the role.

Dr. Downie has authored more than 30 peer-reviewed publications, many centered on innovation in bronchoscopy, early lung cancer diagnosis and medical device development. He has worked extensively in both academic medicine and private practice, led FDA-approved research programs, and served in national leadership roles with the American College of Chest Physicians in the areas of interventional pulmonology, lung cancer, and medical ethics.

“It’s a privilege to join bioAffinity at such a pivotal time,” Dr. Downie said. “I’ve seen firsthand in my practice the need for a noninvasive, accurate and real-time diagnostic for lung cancer. I believe CyPath® Lung is particularly useful in managing indeterminate lung nodules by filling a critical gap in clinical decision-making. I’m excited by the opportunity to expand access to this innovative technology that can save lives.”

In 2007, Dr. Downie left academia and opened a pulmonology practice in rural East Texas, an underserved area with limited access to healthcare. The lack of pulmonary care is exacerbated by an aging population and rising rates of lung disease, including COPD. Most recently, he was the Director of the Lung Nodule Clinic and Interventional Pulmonology at Titus Regional Medical Center.

Dr. Downie earned his PhD in experimental pathology from the State University of New York at Buffalo (SUNY Buffalo) and his medical degree from Northwestern University. He completed residency and fellowship training at the University of North Carolina at Chapel Hill, and subsequently served on the faculty at SUNY Buffalo and the Brody School of Medicine at East Carolina University.

“Dr. Downie brings a rare blend of clinical excellence, research insight, and innovation in delivery of care,” said Maria Zannes, President and CEO of bioAffinity Technologies. “His depth of experience in interventional pulmonology and his passion for early cancer detection make him the ideal leader to guide our clinical strategy as we scale CyPath® Lung and expand our diagnostic platform to additional diseases.”

Prior to pursuing his career in medicine, Dr. Downie was an Olympic bronze medalist at the 1976 Summer Olympics in Montreal as part of Great Britain's men's 4×200-meter freestyle relay swim team. He also won silver and bronze medals at the 1975 World Aquatics Championships and was a four-time NCAA All-American swimmer for the University of Michigan.

“It’s that same spirit of commitment and discipline that has made Dr. Downie a world-class physician respected by his peers throughout the country,” Ms. Zannes said. “We are delighted to welcome him to bioAffinity.”

About CyPath® Lung

CyPath^® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

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. 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 based upon current estimates and assumptions and include statements regarding CyPath® Lung’s usefulness in managing indeterminate lung nodules by filling a critical gap in clinical decision-making, expanding access to CyPath® Lung technology to save lives, Dr. Downie’s contribution to scaling CyPath® Lung, and expanding the Company’s diagnostic platform to additional diseases. 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 accelerate the commercial growth of CyPath® Lung, Dr. Downie’s ability to help expand access to CyPath® Lung technology and guide the Company’s clinical strategy, the Company’s ability to advance new diagnostics for additional diseases, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, 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/20250520582057/en/

“I’ve seen firsthand in my practice the need for a noninvasive, accurate and real-time diagnostic for lung cancer. I believe CyPath® Lung is particularly useful in managing indeterminate lung nodules by filling a critical gap in clinical decision-making."

Contacts

bioAffinity Technologies

Julie Anne Overton

Director of Communications

jao@bioaffinitytech.com

Investor Relations

Dave Gentry

RedChip Companies Inc.

1-800-RED-CHIP (733-2447) or 407-491-4498

BIAF@redchip.com

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bioAffinity Technologies Appoints Dr. Gordon Downie, MD, PhD, as Chief Medical Officer

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