Trinity Biotech Announces TRI-statTM CLIA Submission To FDA

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Jul 2009 - 3:00 PDT

email to a friend   printer friendly   view / write opinions

Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, announced it has submitted its CLIA application for its TRI-stat™ point-of-care HbA1c product to the FDA.

TRI-stat™ is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the last two to three months. The availability of TRI-stat™ will improve overall efficiency of diabetes care by delivering HbA1c values during the patient's visit to the doctor's office. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat™ offers highly accurate results in minutes while eliminating the need for refrigeration found with the other three competing products.

Diabetes is the fourth leading cause of death by disease in the world. According to the International Diabetes Federation, the number of people diagnosed with type 2 diabetes worldwide has increased from 30 million to more than 246 million over the last two decades. This figure is projected to increase further to 380 million by 2025. In the U.S., some 20.8 million Americans (7 percent of the population) have the disease with a further 54 million Americans considered to be pre-diabetic. The test will allow Trinity to address a doctors' office global market of approximately $200 million.

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."

Source
Trinity Biotech