Trinity Biotech plc has submitted its CLIA application for its TRI-stat point-of-care HbA1c product to the FDA. TRI-stat is intended for measuring HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the last three to two months. The launch of this test will improve the efficiency of diabetes care of the patient by delivering HbA1c values during there visit to the doctor's office. TRI-stat uses a patented boronate affinity and two-phase optical system which can be used with a fully automated, simple plug-and-play instrument design to offer highly accurate results in minutes while eliminating the need for refrigeration.
Commenting on the news, Ronan O’Caoimh, CEO, said, Following the successful completion of our CLIA trials in four independent sites in the USA, I am delighted to announce the submission of our TRI-stat CLIA application to the FDA. The test will allow us to address a market which continues to grow significantly each year due to the need for decentralisation of testing to doctors’ offices, the recommendations from the American Diabetes Association and the International Diabetes Federation for more frequent patient monitoring and the ongoing increase in the prevalence of diabetes. We will be showcasing the product at the AACC Clinical Lab Expo in Chicago on 21-23 July, 2009.