Invivoscribe's LeukoStrat® CDx FLT3 Mutation Assay has received approval from the EU Notified Body (BSI Netherlands) and the European Medicines Agency (EMA). This approval allows the assay to be used as a companion diagnostic tool to identify patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) in the European Union and European Economic Area who may be eligible for treatment with Daiichi Sankyo’s VANFLYTA® (quizartinib).
The LeukoStrat® CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene. These mutations are detected in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML.
Clinical Significance
AML is an aggressive blood cancer characterized by the rapid growth of abnormal white blood cells. It has the lowest 5-year survival rate (31.9%) among people diagnosed with leukemia. Approximately 25% of AML patients have a FLT3-ITD mutation, which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.
"Targeting driver mutations linked to new therapies such as VANFLYTA®, is key to improving the lives of AML patients," said Jason Gerhold, Invivoscribe’s V.P. of Global Regulatory, Quality and Clinical Affairs. "Invivoscribe’s Class C CDx assay is now approved by BSI as a CE-marked IVD, offering oncologists another tool to ensure that their patients are provided optimal treatments."
Intended Use
The LeukoStrat® CDx FLT3 Mutation Assay serves as a companion diagnostic for XOSPATA® (gilteritinib fumarate) in regions where it is available, aiding in the assessment of AML patients for whom XOSPATA® treatment is being considered. Similarly, in regions where VANFLYTA® (quizartinib hydrochloride) is available, the assay aids in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® treatment is being considered.
The qualitative, non-automated test is designed for use on the 3500xL or 3500xL Dx Genetic Analyzers.
