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c-KIT Mutation Analysis in Gastrointestinal Stromal Tumors (GISTs)

CPT 81272; 88381
Synonyms
  • Tyrosine Kinase Inhibitor (TKI, Imatinib) Responsiveness

Test Details

Cancer Type

Gastrointestinal stromal tumor (GIST)

Technology Used

Molecular

Turnaround Time

10 - 14 days

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Use

c-KIT is a proto-oncogene that encodes a type III transmembrane tyrosine kinase. c-KIT and its ligand stem cell factor have a key role in survival, proliferation, differentiation, and functional activation of cells.

Special Instructions

This assay currently is not available in New York state.

Limitations

Genomic DNA is purified from the specimen provided. Exons 9, 11, 13, and 17 of c-KIT gene coding are subjected to PCR amplification and bidirectional sequencing in duplicate to identify sequence variations. This assay has a sensitivity to detect approximately 10% of cells containing the c-KIT mutations in a background of nonmutant cells. This assay will not detect the mutation below the sensitivity of this assay.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.

Methodology

Polymerase chain reaction (PCR) and DNA sequencing

Specimen Requirements

Information on collection, storage, and volume

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue or five unstained slides from a paraffin block in 10-μM sections and a matching H&E reference slide

Volume

Formalin-fixed, paraffin-embedded (FFPE) block or five unstained slides from paraffin block in 10-μM sections and a matching H&E reference slide

Minimum Volume

2 mm x 2 mm tumor area with ≥50% tumor

Container

Slides or blocks

Storage Instructions

Maintain blocks and slides at room temperature.

Causes for Rejection

Tumor block containing insufficient tumor tissue or tumor fixed in a heavy metal fixative; broken or stained slides

Collection

Please provide a copy of the pathology report. Please direct any questions regarding this test to oncology customer service at 800-345-4363.

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