*The content of this post only applies to the Idylla™ KRAS & NRAS-BRAF Tests which are CE-marked in Europe in compliance with the EU IVD Directive 98/79/EC. These Tests are not available in the US, but are for Research Use Only (RUO), not for use in diagnostic procedures. Idylla™ CDx MSI Test is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR) (A0220/6) and approved in the US under P250005 (A0220/6). Idylla™ MSI Test is CE-marked in Europe in compliance with the EU IVD Directive 98/79/EC (A0100/6) and cleared in the US under K211181 for Lynch Syndrome (A0160/6).