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The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing.
The study, presented at the American Society of Hematology meeting, also suggested that a moleculary guided strategy may lead to better outcomes than standard of care.
The drug has shown in clinical trials to improve outcomes in patients with FLT3 internal tandem duplication and tyrosine kinase domain mutations.
The phase III trial saw significant overall survival and remission rates in relapsed or treatment refractory acute myeloid leukemia cases treated with the FLT3 inhibitor gilteritinib.
The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
Results from the phase 3 ADMIRAL trial were announced during the American Association for Cancer Research annual meeting.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.