Trinity Biotech Announces Collaboration with University at Buffalo to Commercialize Novel Biomarkers for Sjögren's Syndrome

DUBLIN and NEW YORK, March 18, 2026 (GLOBE NEWSWIRE) -- Trinity Biotech plc (NASDAQ:TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced it has entered into a collaboration agreement with the University at Buffalo, New York ("UB"). The partnership focuses on advancing and commercializing a suite of proprietary biomarkers for the earlier and more accurate detection of Sjögren's Syndrome, one of the most common but underdiagnosed autoimmune diseases.

This collaboration is a key strategic milestone in the continued expansion of Trinity Biotech's New York State Department of Health – approved reference laboratory (NYSDOH), underpinning its strategy to commercialize high value specialty diagnostic tests in the U.S. market.

Advancing Precision Diagnostics for an Under Recognized Autoimmune Disease

Sjögren's Syndrome is a chronic, systemic autoimmune disease that primarily affects moisture producing glands in the eyes and mouth, with potential progressive involvement of multiple organ systems. The disease may affect the nervous system, lungs, and kidneys as well as the function of most other exocrine glands in the human body. Chronic fatigue, joint pain, and neuropathic pain are significant sources of disability.

It is widely underdiagnosed and often mistaken for other autoimmune or inflammatory conditions. As many as 4 million people in the United States may be living with Sjögren's, three times more common than better known related diseases such as lupus and multiple sclerosis. Women account for approximately 90% of cases, and diagnosis is often delayed for years due to heterogeneous clinical presentation¹.

The unmet clinical need remains substantial, with traditional diagnostic pathways heavily reliant on subjective symptom reporting and invasive testing. Trinity Biotech's collaboration with UB aims to unlock a new generation of objective, biomarker based tests to enhance diagnostic speed, accuracy, and clinical confidence.

Scope and Significance of the Collaboration

Under the collaboration agreement:

• Trinity Biotech will codevelop and commercialize proprietary biomarkers discovered by UB faculty researchers and licensed to Trinity Biotech subsidiary IMMCO through Business and Entrepreneur Partnership's Technology Transfer Office, which manages UB's intellectual property and facilitates collaborations between UB faculty researchers and industry partners.
• These biomarkers are designed to improve diagnostic performance for Sjögren's Syndrome, particularly in early stage or seronegative patients.
• Trinity Biotech's NYSDOH approved reference laboratory will serve as the launch platform for the new assays, reinforcing the company's strategy of building a differentiated specialty testing portfolio.
• The collaboration is expected to expand Trinity Biotech's pipeline of autoimmune and immunology focused diagnostic innovations.

The collaborative research that advanced these biomarker discoveries was supported in part through funding from Business and Entrepreneur Partnership's Center for Advanced Technology in Big Data and Health Sciences (UB CAT), which provides applied R&D funding to enable industry partnerships with UB researchers.

"UB CAT's milestone-driven, multi-year funding model delivers sustained support during the critical early stages of product development, equipping companies with the R&D momentum necessary to accelerate their path to commercialization," says Smitha James, Senior Associate Director of Life Sciences Programs and the UB CAT at UB Business and Entrepreneur Partnerships (UB BEP).

John Gillard, President & CEO of Trinity Biotech, commented:

"Sjögren's is a significantly underdiagnosed condition that imposes a major burden on patients. This collaboration further positions Trinity Biotech at the forefront of developing next generation autoimmune diagnostics. Our partnership with the University at Buffalo represents another pivotal step toward building a premium reference lab offering anchored in innovation, clinical value, and proprietary science."

Researchers at the UB emphasized that the biomarker suite - developed through UB faculty research and industry collaboration - has the potential to address longstanding diagnostic gaps and support improved patient outcomes.

"UB Business and Entrepreneur Partnerships connects industry with the university's world-class research expertise and innovation ecosystem," says Per Stromhaug, Senior Associate Vice President for Economic Development. "By facilitating collaborations like this one, we help translate cutting-edge discoveries from UB faculty labs into commercial diagnostics and therapies that can improve patient care."

Strategic Fit for Trinity Biotech

This agreement underscores Trinity Biotech's continued strategic shift toward a higher value, innovation led diagnostics portfolio, leveraging:

• Its enhanced U.S. reference laboratory infrastructure
• Proprietary biomarker development partnerships
• A commercial roadmap focused on specialty autoimmune and metabolic diagnostics

Trinity Biotech expects the collaboration to generate multiple downstream benefits, including expanded clinical partnerships, enhanced payer relevant data packages, and a strengthened platform for future biomarker commercialization.

Forward-Looking Statements

This release includes statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Reform Act"), including but not limited to statements related to Trinity Biotech's cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms "may," "believes," "projects," "expects," "anticipates," or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the company's distributors, losses or system failures with respect to Trinity Biotech's facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech's products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech's intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under "Risk Factors" in Trinity Biotech's annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech's other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

About Trinity Biotech

Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company's website: www.trinitybiotech.com.

About UB's Business and Entrepreneur Partnerships

The University at Buffalo's Business and Entrepreneur Partnerships (BEP) provides a suite of services and programs that connect entrepreneurs, startups and industry with UB's resources—such as cutting-edge research, advanced technologies, expert faculty and a diverse talent pool—to drive innovation, facilitate technology transfer, foster industry collaborations and promote economic and workforce development: www.buffalo.edu/partnerships 

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¹ https://sjogrens.org/understanding-sjogrens/sjogrens-disease-fast-facts