CAT #: FLT3-CDx

LeukoStrat® CDx FLT3 Mutation Assay

  • Overview:

    The fms related tyrosine kinase 3 (FLT3) is one of the most commonly mutated genes in acute myeloid leukemia (AML), occurring in approximately 30% of patients at the time of diagnosis1. Although generally associated with normal cytogenetics where patients have standard risk of relapse, FLT3 mutations have also been identified in sub-groups of patients with chromosomal abnormalities that are associated with high risk of disease relapse2-3.

    The LeukoStrat CDx FLT3 Mutation Assay is an IVD companion diagnostic to aid in the selection of acute myeloid leukemia (AML) patients eligible for treatment with midostaurin (Europe, US) or gilteritinib fumarate (Japan, US), or quizartinib hydrochloride (Japan).

Service Details

  • Indications for Testing:
    • FDA Approved. Service offered at LabPMM LLC. support@labpmm.com
      • midostaurin (US)a
      • gilteritinib fumarate (US)a
    • CE-marked. Service offered at LabPMM GmbH. info@labpmm.de
      • midostaurin (EU)b
    • MHLW/PMDA Approved. Service offered at LabPMM 合同会社. support@labpmm.com
      • gilteritinib fumarate (Japan)c
      • quizartinib hydrochloride (Japan)c

    Intended Use: abcThe LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (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 aspirates of patients diagnosed with acute myelogenous leukemia (AML).

    aThe LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the selection 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 selection of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered. The LeukoStrat CDx FLT3 Mutation Assay is to be performed only at Laboratory for Personalized Molecular Medicine (LabPMM) LLC, a single laboratory site, located at 10222 Barnes Canyon Rd., Bldg. 1, San Diego, CA 92121.

    bIn regions where midostaurin is available, the LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the selection of patients with AML for whom midostaurin treatment is being considered.

    cThe 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.

  • Turnaround Time:
    2-3 business days
  • CPT Codes:

    US CPT Codes

    • 81245
    • 81246

    US Z-Codes

    • ZB410

    JAPAN Reimbursement Points

    • Japan 4200 points

     

  • Specimen Requirements:

    Recommended Specimen Volume (Preservative)

    • 2 mL of peripheral blood (Sodium Heparinabc, EDTAc)
    • 0.5mL of bone marrow (Sodium Heparinabc, EDTAc)

    Minimum Specimen Volume (Preservative)

    • 1mL of peripheral blood (Sodium Heparinabc, EDTAc)
    • 0.25 mL of bone marrow (Sodium Heparinabc, EDTAc)
  • Specimen Storage Conditions:

    20C to 80C; <=7 days

  • Specimen Shipping Conditions:

    Ambient or Cool; Do not freeze

  • Locations Where Test is Performed:

    USA – LabPMM, LLC

    Germany – LabPMM GmbH

    Japan – LabPMM 合同会社

Legal Notice

References

  1. Acute Myeloid Leukemia, Clinical Practice Guidelines in Oncology, (v.2.2014) National Comprehensive Cancer Network.
  2. Lowenberg, B. et al. (1999) “Acute myeloid leukemia.” N Engl J Med 341(14):1051-62.
  3. Thiede, C. et al. (2002) “Analysis of FLT3-activating mutations in 979 patients with acute myelogenous leukemia: association with FAB and identification of subgroups with poor prognosis.” Blood 99(12): 4326-35.
  4. Nakao, M. et al. (1996) “Internal tandem duplication of the FLT3 gene found in acute myeloid leukemia.” Leukemia 10(12):1911-18.
  5. Yamamoto, Y, Kiyoi H, Nakano Y, Suzuki R, Kodera Y, Miyawaki S, Asou N, Kuriyama K, Yagasaki F, Shimazaki C, Akiyama H, Saito K, Nishimura M, Motoji T, Shinagawa K, Takeshita A, Saito H, Ueda R, Ohno R, Naoe T. Activating mutation of D835 within the activation loop of FLT3 in human hematologic malignancies. Blood, 2001, 97(8):2434-9.
  6. Gilliland, D.G. and Griffin, JD. (2002) The roles of FLT3 in hematopoiesis and leukemia. Blood 100(5):1532-154.
  7. Yanada M, et al. (2005) Prognostic significance of FLT3 internal tandem duplication and tyrosine kinase domain mutations for acute myeloid leukemia: a meta-analysis.Leukemia 19 (8): 1345-1349.Leukemia 19 (8): 1345-1349.

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