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Trinity Biotech gets Sanctioned by the FDA for an Innovative Device HbA1c

Trinity biotech plc is one of the developer and manufacturer in the market and thus leads the market for manufacturing and developing the diagnostic products for the point of care and clinical laboratory markets.  This leading manufacture has made a public announcement abpout an agreement to solely supply Menarini Diagnostics with the new Premier Hb9210 (PDx) instrument for distribution in European territories.

The Premier Hb9210 instrument is an entirely mechanized system that measures HbA1c in high and low throughput clinical laboratories. Also known as glycated hemoglobin is a measure of a patient’s average blood sugar control over the last two to three months.

Menarini being one of the Europe’s leading pharmaceutical and diagnostics companies with a turnover of EUR 2.6billion and 12,000 employees, is the market leader in HbA1c measurement in Europe. Menarini have a market share of 40% in the European HbA1c market, a large installed base of equipment and over 20 years know-how in HbA1c measurement. Hbac1 is among the speedily developing market in the field of diagnostics industry.

Diabetes is the fourth leading cause of death by disease in the world and the number of diabetic patients is expected to reach 370 million in 2030. In the U.S. alone some 20.8 million Americans (7 percent of the population) have the disease with a full 54 million Americans considered to be pre-diabetic. The total laboratory HbA1c market worldwide is expected to reach $272 million by 2012.  There are several explicit features of this device as it produces results in a matter of 59 seconds and above all it is updated with the latest technologies of touch screen facility and does not need any on site maintenance

As mentioned in the comment in the announcement by Trinity Biotech’s CEO, Mr. Ronan O’Caoimh said. The launch of the Premier Hb9210 instrument through Menarini will secure a significant market share for Trinity Biotech in the European market in the short term. The launch of this instrument in April will allow us to target a rapidly growing global market estimated to be worth $272 million by 2012 with a best in class product. We will file a U.S. FDA submission in April and simultaneously we will file for authorization in China, Brazil and other significant markets.