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Recent Device Approvals: therascreen KRAS RGQ PCR Kit

The U.S. Food and Drug Administration has recently approved the therascreen KRAS RGQ PCR Kit to be marketed.   The therascreen KRAS RGQ PCR Kit is an automated molecular assay designed to detect the presence of seven mutations in the K-ras gene in colorectal cancer cells.  In normal tissue, the K-ras protein transmits signals in cells to regulate cell growth and cell death. In colorectal cancer tissue, mutations in the K-ras gene cause an altered form of the K-ras protein and results in abnormal functioning of the protein.  For more information, please see http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm400569.htm


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