Trinity Biotech received U.S. Food and Drug Administration 510(k) clearance for the Premier Resolution System, an automated analyzer for the accurate & precise quantification of hemoglobins F and A2, and the detection of >200 hemoglobin variants. The Premier Resolution System is now cleared for sale in the United States.
The Premier Resolution System is a lab-based hemoglobin diagnostic system consisting of a high-performance liquid chromatographic analyzer, reagents, analytical column, and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC). The Premier Resolution System is a modern successor to Trinity Biotech’s Ultra System that held a leading position in the U.S. hemoglobin variant diagnostic market.
The hemoglobin variants detected by the Premier Resolution can cause a range of medical conditions, including thalassemias and Sickle Cell Disease, which significantly impact the ability of red blood cells to efficiently transport oxygen. The incidence of these variant conditions has been steadily growing worldwide as global migration increases, and with this increase the need for accurate diagnostic methods has become ever more important, the company says. The Premier Resolution gives laboratories the tools to easily identify clinically important variants.
“We welcome the news that our Premier Resolution has received 510(k) clearance from the FDA. Our intention is to regain our market leading position in hemoglobin variant detection with a modern successor to the highly regarded Ultra platform,” says Aris Kekedjian, chairman and CEO of Trinity Biotech. “The Premier Resolution System builds on our Ion Exchange technology reputation for excellence in the separation and identification of a broad range of rare hemoglobin variants. It features a high degree of advanced feature flexibility and a market leading combination of accuracy, speed and value. We also expect this important 510(k) clearance from the FDA to drive further penetration of the Premier Resolution System in key global markets, including Brazil, and allow us to begin the regulatory process for the Chinese market.
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Kekedjian added: “This is an important milestone in the transformation of Trinity Biotech, which is anchored by the expansion of our hemoglobin and diabetes franchises. The Premier Resolution represents the first in a number of expected product roll-outs and investments in this space, with further product upgrades in our core diabetes HbA1c platform expected to follow in the new year.”
Featured image: The Premier Resolution software is a haemoglobin fractionation system that employs the principles of ion-exchange chromatography and high performance liquid chromatography. Photo: Trinity Biotech