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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…

In Vitro Diagnostic Clinical Performance Study Plan to determine HER2 and PD-L1 status of HER2-positive gastric cancer specimens.

Supplement to Clinical Study Protocol: D702AC00001 (Artemide-Gastric01)

To support the AstraZeneca ARTEMIDE-Gastric01 clinical trial by testing for PD-L1 and HER2 expression in FFPE tumor specimens for eligibility and stratification.The primary objective of this clinical performance study is to evaluate the…