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c-KIT Mutation Analysis in Gastrointestinal Stromal Tumors (GISTs)
Test Code510870
Alias/See Also
Gastrointestinal Stromal Tumors (GISTs)
CPT Codes
83891; 83894(x4); 83898(x12); 83909(x8);
Preferred 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
Minimum Volume
2 mm x 2 mm tumor area with =50% tumor
Instructions
Maintain blocks and slides at room temperature
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Tumor block containing insufficient tumor tissue or tumor fixed in a heavy metal fixative; broken or stained slides
Methodology
Polymerase chain reaction (PCR) and DNA sequencing
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.
