The content of this post is only applicable to Idylla™ CDx MSI Test, which is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR) and approved in the US under P250005, and Idylla™ NRAS-BRAF & KRAS Mutation Tests, which are CE-marked in Europe in compliance with the EU IVD Directive 98/79/EC, CE-IVD certification under IVDR is in progress. Idylla™ NRAS-BRAF & KRAS Mutation Assays are for Research Use Only (RUO), not for use in diagnostic procedures in the US.