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Japan’s Nihon Trim Gets U.S. FDA Clearance For Warfarin Diagnostic

This article was originally published in PharmAsia News

Executive Summary

U.S. FDA has cleared Japan's Nihon Trim subsidiary TrimGen to market its genotyping kit for warfarin anti-coagulant. The TrimGen kits develop genetic profiles of patients to test how they would react to warfarin as a treatment against heart attacks, strokes or blood clots without suffering severe bleeding. Nihon Trim already has four other types of kits on the U.S. market, but the 90-minute TrimGen kit is the first designed for use with Roche's LightCyclere Real-Time PCR System. Nihon Trim plans to team with another pharmaceutical firm to sell the kits, as early as this summer. (Click here for more - a subscription may be required

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