Trinity Biotech's Premier Resolution System Secures FDA 510(k) Clearance for Advanced Hemoglobin Variant Detection

Tuesday, August 08, 2023

Trinity Biotech has achieved a major regulatory milestone with the FDA's clearance of its Premier Resolution System through the 510(k) pathway. This cutting-edge automated analyzer offers precise quantification of hemoglobins F and A2 and can detect over 200 hemoglobin variants. The system is now authorized for commercial distribution within the United States.

Designed specifically for laboratory-based hemoglobin diagnostics, the Premier Resolution System includes a high-performance liquid chromatographic analyzer, reagents, analytical column, and software. This powerful combination enables the fractionation and quantitation of fetal hemoglobin (Hb F) and hemoglobin A2 (Hb A2), along with the preliminary identification of abnormal hemoglobin variants using ion-exchange high-performance liquid chromatography (HPLC) techniques. The system builds on the success of Trinity Biotech's Ultra System, a pioneering product in the U.S. hemoglobin variant diagnostic market.

The Premier Resolution System's ability to identify various hemoglobin variants is crucial due to their association with medical conditions such as thalassemias and Sickle Cell Disease, which affect the efficient transport of oxygen by red blood cells. The increasing prevalence of these variant-related disorders globally highlights the need for accurate diagnostic tools. The Premier Resolution System equips laboratories to promptly and accurately identify clinically significant variants.

Aris Kekedjian, Chairman, and CEO of Trinity Biotech, expressed excitement over this achievement, emphasizing the company's commitment to regaining its leadership in hemoglobin variant detection through the modern Premier Resolution platform. Leveraging Trinity Biotech's established Ion Exchange technology, the Premier Resolution System excels in separating and identifying a wide range of rare hemoglobin variants, providing exceptional speed, accuracy, and value. This FDA clearance is expected to drive the system's adoption in key global markets, including Brazil, and facilitate regulatory processes for market entry in China.

Kekedjian underscored the milestone's significance in Trinity Biotech's transformation journey, which includes expansions in the hemoglobin and diabetes domains. Following the launch of the Premier Resolution System, the company plans to introduce additional products and make investments in this sector, including upgrades to the core diabetes HbA1c platform in the upcoming year.


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