1 December 2019

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.

The LeukoStrat® CDx FLT3 Mutation Assay from Invivoscribe enables laboratories and physicians to support patients with local access to high-quality, diagnostic tests that improve treatment.

Assay overview

  • Ready-to-use FLT3 ITD & TKD master mixes and run controls
  • Short turnaround protocol (1-2 business days)
  • Software included
    • From run planning to analysis with local interpretation
  • Mutant: wild type ratio results
    • Automatically evaluated against the midostaurin & gilteritinib fumarate clinical cut-offs
  • Complete technical support
  • CE-IVD marked including software developed under ISO 13485
LeukoStrat® CDx FLT3 Mutation Assay (K-412-0291)
LeukoStrat® CDx FLT3 Mutation Assay Software (K-412-0281)

Intended use

The LeukoStrat® CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspiratesof patients diagnosed with acute myelogenous leukemia (AML).

In regions where midostaurin is available, the assay is used as an aid in the assessment of patients with AML for whom RYDAPT®(midostaurin) treatment is being considered.

In regions where gilteritinib fumarate is available, the assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib fumarate) treatment is being considered.

Assay clinical performance evaluation – Midostaurin drug efficacy

The safety and efficacy of the LeukoStrat® CDx FLT3 Mutation Assay was assessed during a bridging study, corresponding to the Phase III CPKC412A2301 (RATIFY) clinical study of midostaurin in newly diagnosed AML patients with FLT3 mutations.

Figure 1: Kaplan-Meier for overall survival in the RATIFY trial in the CTA+ population.

Assay clinical performance evaluation – Gilteritinib drug efficacy

European Commission approval of gilteritinib is based on Phase 3 ADMIRAL trial results which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML. The ADMIRAL study demonstrated that gilteritinib resulted in a statistically significant improvement in median overall survival (9.3 months) compared to salvage chemotherapy (5.6 months) when patients were selected with the LeukoStrat CDx FLT3 Mutation Assay.

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