FAQ

Frequently Asked Questions

FAQ

Frequently
Asked
Questions

  • FDA Approved:
    • The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered.
    • The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered.
    • The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered.
  • CE-Marked:
    • In regions where midostaurin is available, the LeukoStrat CDx FLT3 Mutation 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 LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib fumarate) treatment is being considered.
  • MHLW/PMDA Approved:
    • The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom Gilteritinib Fumarate treatment is being considered.
    • The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom Quizartinib Hydrochloride treatment is being considered.

  • The assay can be purchased as a diagnostic kit for use in your own laboratory. Alternatively, a sample can be sent to LabPMM for testing and the results will be sent to your facility within 2-3 business days.

  • Our LeukoStrat® CDx FLT3 Mutation Assay kit includes TKD and ITD master mixes, TKD positive and negative controls, ITD positive and negative controls, an extraction control, Taq DNA polymerase*, EcoRV* and buffer*, and LeukoStrat® CDx FLT3 Mutation Assay software. This comprehensive package is simple to use, reduces user error, and has a rapid TAT. (*not included in catalog no. K4120291)

  • The LeukoStrat® CDx FLT3 ITD Mutation assay was validated using the ABI 3500xL Dx Genetic Analyzer, if an alternate instrument is used it would need to be validated.

  • Wild-type and ITD peaks must be reported in both green and blue for a valid result. Peaks in a single color may be a result of crosstalk or unspecific products.

  • The difference between the SR and AR is a semantic one, but the distinction is important. The LeukoStrat® CDx FLT3 Mutation Assay compares two signals from the ABI 3500xL Dx instrument to calculate the relationship (signal ratio) between the mutated and unmutated results. To calculate a true allelic ratio, one would need to know exactly the number of mutated alleles present in each cell.

  • After completion of digestion, the LeukoStrat® CDx FLT3 Mutation assay plate may be stored at 2°C to 8°C, keeping the light exposure to a minimum, for up to 72 hours before capillary electrophoresis.

  • Our service requires at least 0.5 mL of bone marrow aspirate or 2.0 mL of peripheral blood in a sodium heparin or EDTA tube. Our kit requires at least 0.25 mL of bone marrow aspirate or 1.0 mL of peripheral blood in a sodium heparin or EDTA tube.

  • There is no preferred specimen type between bone marrow aspirate or peripheral blood. During clinical validation both specimen types were shown to be equivalent.

  • PCR products generated using the LeukoStrat® CDx FLT3 Mutation assay can be stored at 2°C to 8°C, keeping the light exposure to a minimum, for up to 72 hours before capillary electrophoresis.

  • No, unfortunately specimens require special processing before DNA extraction for use with the Leukostrat® CDx FLT3 Mutation Assay.

  • No, due to the way a specimen is processed for the assay the specimen must not be frozen.

  • Specimens should be stored between 2°C and 8°C until shipment.

  • Specimens must arrive at LabPMM within seven days of collection.

  • 2-3 business days.