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TrimGen wins FDA approval for warfarin genotyping kit

TrimGen, a molecular diagnostic company, has received the FDA 510(k) clearance to market its eQ-PCR LC warfarin genotyping kit.

According to TrimGen, its eQ-PCR LC warfarin genotyping assay will be used as an aid in the identification of patients who may be at risk of warfarin sensitivity.

Howard Doong of TrimGen, said: “The FDA approval is an important milestone for TrimGen. It indicates that our eQ-PCR technology has met the regulatory challenges; our efforts warrant not only a simple, accurate diagnostic test but also the future commercial success of the company.”