Trinity Biotech announced recommencement of trials
The product is now demonstrating the identical clinical performance witnessed in our European CE marking trials early in 2014 and in the independent clinical evaluation carried out at Hennepin County Medical Centre, Minneapolis and published at the AACC meeting in July 2014.
With the clinical trial restarted, management estimate that the entire trial process, consisting of patient sampling, data collection, cardiologist adjudication and statistical analysis, will be completed by the end of July, 2015 with FDA submission planned for August, 2015.
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Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide.