Trinity Biotech announced that its New York-based reference laboratory, Immco Diagnostics, has applied for a Proprietary Laboratory Analyses (PLA) code for its Early Sjögren’s Syndrome Test Panel to allow for an optimized market access strategy to deliver broader patient access and improved profitability.

It is estimated that up to approximately 3 million people in the United States have Sjögren’s Syndrome, making it one of the most prevalent autoimmune syndromes. Individuals with Sjögren’s Syndrome suffer most notably from dry eyes and dry mouths, as well as difficulty swallowing, increased dental cavities, joint pain, and swelling, among other ailments. There is an acute shortage of evidence-based standardized screening tools for Sjögren’s Syndrome, contributing to a prolonged diagnostic journey and an overall trend of underdiagnosis, according to the company. The provision of effective diagnostic tools can significantly improve clinical outcomes and reduce the cost burden of care in Sjögren’s Syndrome disease management for payors and health systems.

The Early Sjögren’s Syndrome Test Panel is a valuable immunological tool for clinicians to both identify patients earlier, when therapeutic intervention is most effective, and to also identify patient cohorts most at risk of progression to Sjögren’s Syndrome.

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A PLA code is a distinct, specific code assigned to a particular test and approved by the American Medical Association’s (AMA) Current Procedural Terminology (CPT) Editorial Panel. PLA codes must be requested by the clinical laboratory or manufacturer that offers the test. The PLA code allows the clinical lab or manufacturer to preferentially differentiate the test in terms of payor pricing and avoid the utilization of multiple generic lower value CPT codes, ultimately incentivising Immco Diagnostic’s commercial partners to provide broader patient access to this key diagnostic tool. 

Subject to approval, the company expects the PLA code for the Early Sjögren’s Syndrome Test Panel to become effective in Q3 2024, which should allow Immco Diagnostics to implement a further optimized market access strategy, aimed at delivering better patient access, while affording improved profitability for both Immco Diagnostics and its commercialization partners, the company says.

Immco Diagnostic’s laboratory provides specialized autoimmune diagnostic solutions to health networks including the largest lab chains in the U.S.