Trinity Biotech Partners with University at Buffalo to Develop Novel Sjögren's Syndrome Biomarkers
Key Insights
Trinity Biotech has entered into a collaboration with the University at Buffalo to commercialize proprietary biomarkers (search) for earlier and more accurate detection of Sjögren's Syndrome (search), addressing a significant diagnostic gap in autoimmune disease (search) management.
The partnership targets Sjögren's Syndrome (search), which affects up to 4 million Americans and is three times more common than lupus (search) and multiple sclerosis (search), yet remains widely underdiagnosed with women comprising approximately 90% of cases.
The biomarkers (search) are specifically designed to improve diagnostic performance in early-stage or seronegative patients, utilizing Trinity Biotech's NYSDOH-approved reference laboratory as the launch platform for these innovative assays.
Trinity Biotech plc has announced a strategic collaboration with the University at Buffalo to advance and commercialize a suite of proprietary biomarkers (search) for the earlier and more accurate detection of Sjögren's Syndrome (search), one of the most common but underdiagnosed autoimmune diseases. The partnership represents a key milestone in Trinity Biotech's expansion of its New York State Department of Health-approved reference laboratory and its strategy to commercialize high-value specialty diagnostic tests in the U.S. market.
Addressing a Critical Diagnostic Gap
Sjögren's Syndrome (search) is a chronic, systemic autoimmune disease (search) that primarily affects moisture-producing glands in the eyes and mouth, with potential progressive involvement of multiple organ systems including the nervous system, lungs, and kidneys. The disease significantly impacts patients through chronic fatigue, joint pain, and neuropathic pain, which serve as major sources of disability.
Despite its prevalence, Sjögren's Syndrome (search) remains widely underdiagnosed and is often mistaken for other autoimmune or inflammatory conditions. According to the collaboration announcement, as many as 4 million people in the United States may be living with Sjögren's, making it three times more common than better-known related diseases such as lupus (search) and multiple sclerosis (search). Women account for approximately 90% of cases, and diagnosis is often delayed for years due to heterogeneous clinical presentation.
The unmet clinical need remains substantial, with traditional diagnostic pathways heavily reliant on subjective symptom reporting and invasive testing. Trinity Biotech's collaboration with the University at Buffalo aims to unlock a new generation of objective, biomarker-based tests to enhance diagnostic speed, accuracy, and clinical confidence.
Collaboration Framework and Innovation
Under the collaboration agreement, Trinity Biotech will co-develop and commercialize proprietary biomarkers (search) discovered by University at Buffalo faculty researchers and licensed to Trinity Biotech subsidiary IMMCO (search) through the university's Technology Transfer Office. These biomarkers are specifically designed to improve diagnostic performance for Sjögren's Syndrome (search), 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 the university's Center for Advanced Technology in Big Data and Health Sciences (UB CAT), which provides applied R&D funding to enable industry partnerships with university 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," said Smitha James, Senior Associate Director of Life Sciences Programs and the UB CAT at UB Business and Entrepreneur Partnerships.
Leadership Perspectives
John Gillard, President & CEO of Trinity Biotech, emphasized the clinical significance of the partnership: "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."
University at Buffalo researchers emphasized that the biomarker suite, developed through faculty research and industry collaboration, has the potential to address longstanding diagnostic gaps and support improved patient outcomes.
Per Stromhaug, Senior Associate Vice President for Economic Development at the university, noted: "UB Business and Entrepreneur Partnerships connects industry with the university's world-class research expertise and innovation ecosystem. 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 Implications
This agreement underscores Trinity Biotech's continued strategic shift toward a higher-value, innovation-led diagnostics portfolio. The collaboration leverages the company's enhanced U.S. reference laboratory infrastructure, proprietary biomarker development partnerships, and 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. The partnership positions the company to address the substantial unmet need in Sjögren's Syndrome (search) diagnosis while building capabilities for broader autoimmune diagnostic applications.