Trinity Biotech announces that it has commenced CLIA trials for its TRI-stat™ point-of-care HbA1c product.

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 patients’ 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 US, some 20.8 million Americans (7% of the population) have the disease, with a full 54 million Americans considered to be pre-diabetic.

Commenting on the news, Ronan O’ Caoimh, CEO, said, "We are pleased to meet this important milestone event. TRI-stat has successfully passed internal and external research trials and we are confident of a successful outcome in the CLIA trials. These trials are commencing this week and will take approximately 4 to 6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval. The test will allow us to address a doctors’ office global market in excess of $200 million, which consists of three competitors, one of which is the dominant player. This market also 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."