Invivoscribe Announces IVDR Approval of the LeukoStrat CDx FLT3 Mutation Assay
“Today we are pleased to announce that Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the stringent new IVDR (Regulation (EU) 2017/746) requirements. Invivoscribe is one of the first companies in the world to gain an IVDR approval of a CDx assay. IVDR is […]