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An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples in a first line setting from patients diagnosed with metastatic Colorectal Cancer (mCRC) to determine the KRAS G12C mutation status as part of the inclusion criteria into the Amgen Phase III clinical trial (Protocol No 20210081) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit.

To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen*s Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of…