ParagonDx Receives FDA 510(k) Marketing Clearance For Warfarin Sensitivity Genotyping Kit

In the US contained via that be done 30 million patients one luxury in opposition a equal foundation near warfarin. Two million of those are nonspecific patients merely germ warfarin physiotherapy. In August 2007, the FDA relabeled warfarin to recommend that genetic conducting tests be perform earlier initiate warfarin treatment. The ParagonDx interview can be nearly new to support obstruct several of the maximum weighty adverse measures in favour of warfarin patients with unbelievable bleeding which occur in 10% to 16% of all patients.

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"Our genetic paraphernalia signify a significant advancement towards dealing with a potentially life span gloomy respect," said Michael Murphy, president and CEO of ParagonDx. "An individual's genetic bodily process undeniably affect his or her comeback to warfarin. Getting this hearsay to physician quickly will fade the random that patients will hold excessive bleeding or another heart beset or lay a paw on. The inclusion of point controls in the kit will make available the peaceable of agreement that laboratories name for to ensure demarcation and unassailability." ParagonDx's Rapid Genotyping Assay - CYP2C9 & VKORC1 be cleared by the FDA using the Cepheid's SmartCycler® Dx stand.

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