Detect activating mutations in KIT and PDGFRA. Predict response to tyrosine kinase inhibitor (TKI) therapy.
Massively Parallel Sequencing
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Diff-Quik and Papanicolaou stained cytology smears are also acceptable. Number of slides needed is dependent on the tumor cellularity of the smear. Slide(s) will be destroyed during testing process and will not be returned to client. Protect from excessive heat. Transport block and/or slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.
Resections: Transport 8 unstained 5-micron slides. (Min: 5 slides)
Small Biopsies: Transport 15 unstained 5-micron slides. (Min: 10 slides)
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Less than 10 percent tumor. Specimens fixed/processed in heavy metal fixatives. Decalcified specimens. FNA smears with less than 50 tumor cells.
Include surgical pathology report.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Refer to report
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
A full list of the targeted genes and regions is listed in the Additional Technical Information.
88381; 81272; 81314
|Component Test Code*||Component Chart Name||LOINC|
- c-kit Mutation Analysis in Gastrointestinal Stromal Tumors (GISTs)
- CD117 KIT
- GIST Mutation
- KIT exons 9, 11, 13, 14, 17, and 18
- KIT mutation
- PDGFRA exons 12, 14 and 18
- PDGFRA Mutation in Gastrointestinal Stromal Tumors (GISTs)
- TKI resistance
- TKI sensitivity