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Test Directory c-kit Mutation Analysis, Cell-based

c-kit Mutation Analysis, Cell-based

Test Summary

Activating c-KIT mutations have been identified in various human cancers. c-KIT exon 8 and 17 mutations have been described in patients with CBF-AMLs and usually confer a poor prognosis with increased relapse rate. c-KIT exon 9, 11, 13, 17 mutations have been reported in nearly 90% GIST patients. The presence mutation usually predict poor survival. c-KIT exon 17 mutation has been reported in patients with systemic mastocytosis.

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

3 mL whole blood or Formalin fixed paraffin embedded tissue. Bone marrow and Cell pellet are acceptable.

Minimum Volume

1 mL

Instructions

Submission of whole blood (preferred): Follow standard whole blood Collection procedure. Collect 3-5 mL whole blood samples in EDTA tube. Blood samples are shipped at room temperature or 4 degrees C. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability. Cell Pellet Instructions: This assay is also designed for the remnant cell pellet from Cytogenetics. The cell pellet usually fixed should be transported at room temperature or refrigerated to the laboratory as soon as possible. Please provide a copy of the Cytogenetics report.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Whole blood and formalin-fixed paraffin-embedded tissue block: Room temperature
Bone marrow: Refrigerated (cold packs)

Specimen Stability

Whole blood and Bone marrow
Room temperature: 7 days
Refrigerated: 14 days
Frozen: Unacceptable
Tissue
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Do not fr

Limitations

N/A

Other Acceptable Specimens

Bone marrow collected in an EDTA (lavender-top) tube • Cell pellet

Unacceptable Specimens

N/A

Order Code

CKITMT

EPIC (Premier) Code

LAB5221

Includes

N/A

CPT Code

81272

Billing Code

670208

CPT Statement

Methodology

Next Generation Sequencing

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Monday, Thursday; Report available: 3 days