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KIT (D816V) Mutation*

Test Code



Mastocytosis, Seminoma, Human systemic mast cell disease

KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) is an in vitro diagnostic test intended for qualitative polymerase chain reaction (PCR) detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis. The KIT D816V mutational assay is indicated as an aid in the selection of ASM patients for whom Gleevec® (imatinib mesylate) treatment is being considered.


Polymerase Chain Reaction

* Performed by affiliate laboratory

Turnaround Time

5-7 days

Specimen Requirements

Whole Blood: Transport 5 mL whole blood. (Min: 1 mL)
Bone Marrow: Transport 3 mL bone marrow. (Min: 1 mL)

Specimen Stability
Storage & Handling

Ship refrigerated only.

Causes for Rejection

FFPE tumor tissue. Fresh Tissue. Clotted or grossly hemolyzed specimens.

Reference Range

Detected − KIT D816V point mutation detected


Aids in the diagnosis of mastocytosis. Provide prognostic and predictive information for tyrosine kinase inhibitor (TKI) therapy planning.