NEW YORK — Invivoscribe said on Tuesday that its LeukoStrat CDx FLT3 Mutation Assay has been certified for CE marking by BSI, a notified body in the Netherlands, and approved by the European Medicines Agency as a companion diagnostic for Daiichi Sankyo's Vanflyta (quizartinib).
The PCR-based test detects internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene from DNA extracted from peripheral blood or bone marrow aspirates of patients with acute myelogenous leukemia (AML).
The test may now be used to select newly diagnosed FLT3-ITD-positive AML patients in the EU and European Economic Area who may be eligible to receive Vanflyta, according to San Diego-based Invivoscribe.
The LeukoStrat CDx FLT3 Mutation Assay was approved by the US Food and Drug Administration earlier this year for use in selecting Vanflyta-eligible patients. It was approved for this indication in Japan in 2019 and received approval under Europe's In Vitro Diagnostic Regulation in May.
The assay is also approved in the US for use as a companion diagnostic for AML patients considering treatment with Novartis' Rydapt (midostaurin) and Astellas Pharma's Xospata (gilteritinib).