Trinity Biotech Announces FDA Approval for HBA1c Analyzer

Trinity Biotech plc has announced that it has obtained FDA approval for its Premier Hb9210 analyzer. The Premier instrument is fully automated and measures HbA1c in high and low throughput clinical laboratories.

HbA1c is a glycated haemoglobin that is formed in a non-enzymatic glycation pathway by haemoglobin’s exposure to plasma glucose. The fraction of glycated haemoglobin increases as the amount of plasma glucose increases. As such, HbA1c can be used as a measure of a patients average blood glucose levels over the previous 2 or 3 months.

The current worldwide prevalence of diabetes is estimated to be approximately 250 million and is expected to reach 380 million people by 2025. In the US it is estimated that 12.9% of the population over the age of 20 have diabetes, 40% of Americans remain undiagnosed. The worldwide costs of diabetes in 2007 were approximately $232 billion and this is expected to increase to $302 billion by 2025.

The Premier Hb9210 is fully automated and uses patented boronate affinity technology, which eliminates interference from haemoglobin variants. Results are available in one minute, making it the fastest test on the market. Users also benefit from state of the art software and touch-screen technology.

FDA approval enables the instrument to be launched and sold in the United States and will greatly facilitate sales in other international jurisdictions. The instrument has already been CE marked for sale in Europe and was formally launched in Quarter 2, 2011.

Commenting on the announcement, Trinity Biotech's CEO, Mr Ronan O'Caoimh, said, "HbA1c testing is already a US$300 million global market with enormous growth potential. We have now the fastest, most user friendly and state of the art HbA1c analyser in the world. FDA approval of the instrument, in conjunction with its recent CE marking, now gives us access to the US and European markets, the two most important individual markets in the world, and will accelerate the approval process in other key markets such as Brazil and China. Together with our partners, Menarini in Europe and Fisher in the USA, we are ideally positioned to become a significant and serious player in the global HbA1c market in the coming years."