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KIT (D816V) Mutation

Test Code

M KIT P*

Associations

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.

Methodology

Allele specific PCR of exon 17.



* Performed by affiliate laboratory

Turnaround Time

5-7 days

Specimen Requirements

Paraffin embedded tissue

Specimen Stability
Ambient: Indefinitely; Refrigerated: Indefinitely
Storage & Handling

Ship ambient
In extreme hot weather, ship with a cool pack

Causes for Rejection

Frozen Unacceptable;  Specimens fixed/processed in alternative fixatives or heavy metal fixatives (B-4 or B-5); De-calcified specimens

Reference Range

Detected − KIT D816V point mutation detected

Description

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