LeukoStrat® CDx FLT3 Mutation Assay
The only CE-IVD marked assay for selection of acute myeloid leukemia (AML) patients eligible for treatment with midostaurin or gilteritinib fumarate.
This NGS-based, targeted, deep-sequencing assay detects & monitors DNA sequences specific to identified mutations from the primary sample identified at diagnosis with an allelic sensitivity level of 5Ă—10-5.
This news item was updated in July 2024
Stratifying acute myeloid leukemia (AML) disease according to molecular genetic alterations, such as those in the fms related tyrosine kinase 3 (FLT3) gene, aids in prognosis1. The most frequent and clinically significant type of FLT3 mutation is an internal tandem duplication (ITD) in the juxtamembrane domain2. The FLT3-ITD mutation occurs in about 25% of newly diagnosed AML patients and is associated with an increased risk of relapse and lower overall survival rate1. Unlike flow cytometry assays which require fresh sample and are highly subjective, the FLT3 ITD MRD Assay, a targeted, deep sequencing assay can be used with previously isolated DNA to detect ITD mutations at an allelic sensitivity level of 5×10-5.
Invivoscribe’s FLT3 ITD MRD Assay includes 24 unique dual-indices enabling the ability to multiplex multiple samples. This kit configuration provides laboratories the flexibility to scale testing for variable AML MRD research needs. To further simplify your workflow, our FLT3 ITD MRD Software can easily be integrated into down-stream reporting systems and/or LIMS to automate data analysis.
FLT3 ITD MRD Assay (MiSeq) (14120019) |
FLT3 ITD MRD v1.2 Software (MiSeq) (14120029) |
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