Invivoscribe has secured approval from the US Food and Drug Administration (FDA) for its LeukoStrat CDxFLT3 Mutation Assay to select patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia (AML) for Daiichi Sankyo’s Vanflyta (quizartinib).
These patients will be able to receive treatment with Vanflyta, which is claimed to be the first FLT3 inhibitor approved in the US for this indication.
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Designed to run on the 3500xL Dx Genetic Analyser, LeukoStrat CDxFLT3is a polymerase chain reaction-based in vitro diagnostic test.
It is intended to detect internal tandem duplication (ITD) and tyrosine kinase domain mutations D835 and I836 in the FLT3gene in genomic DNA extracted from mononuclear cells.
The cells are sourced from either peripheral blood or bone marrow aspirates of AML patients.
Invivoscribe CSO, CEO, and founder Jeffrey Miller said: “FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to Vanflyta is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML.
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By GlobalData“Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with Vanflyta and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients.”
Earlier, Japan’s Pharmaceuticals and Medical Devices Agency approved this assay as a companion diagnostic to select FLT3-ITD positive AML patients eligible for Vanflyta in the country.
Last month, Invivoscribe joined forces with Complete Genomics for the development and commercialisation of biomarker tests for cancer and oncology research.
