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KRAS and NRAS Mutation Analysis, Cell-based
Test Code35799
CPT Codes
81275, 81276, 81311
Preferred Specimen
Formalin-fixed, paraffin embedded tissue block
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate • 4 slides
Other Acceptable Specimens
5 mL whole blood or 3 mL bone marrow aspirate collected in: EDTA (lavender-top) tube, or sodium heparin (green-top) tube • 8 unstained positively charged slides
Instructions
Submission of formalin-fixed, paraffin-embedded tissue is the preferred sample type. Other sample types listed are acceptable for testing. For submission of paraffin block, another preferred specimen type, tissue source and block ID are required on the requisition form.
A pathology report must be submitted.
Whole Blood: Follow standard whole blood collection procedures. Collect 3-5 mL whole blood in an EDTA tube. Record sample type, collection time and date onto tube and requisition form.
Bone Marrow collection, the notation of sample type, collection time and date onto the tube and requisition form is required. Ship sample at refrigerated temperature or room temperature. Ship immediately to maintain stability.
A pathology report must be submitted.
Whole Blood: Follow standard whole blood collection procedures. Collect 3-5 mL whole blood in an EDTA tube. Record sample type, collection time and date onto tube and requisition form.
Bone Marrow collection, the notation of sample type, collection time and date onto the tube and requisition form is required. Ship sample at refrigerated temperature or room temperature. Ship immediately to maintain stability.
Transport Temperature
Room temperature
Specimen Stability
FFPE and Unstained slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen: unacceptable
Whole blood and bone marrow aspirate
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: unacceptable
Whole blood and bone marrow aspirate
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
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. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Tuesday-Saturday Morning Report available: 4 Days
Reference Range
| KRAS Mutation, Cell-based | Not detected |
| NRAS Mutation, Cell-based | Not detected |
Clinical Significance
Recent studies have shown that mutations in KRAS and NRAS exons 2, 3, and 4 have influence on response to anti-EGFR therapy. Testing these genes will aid in selection of patients who will likely respond to anti-EGFR therapy. KRAS, along with others, is a clinically actionable biomarker in NSCLC (non-small cell lung cancer) and other tumor types. Currently, in NSCLC the KRAS G12C mutation is prevalent in approximately 13% of patients and represents nearly half (44%) of all KRAS mutations. Investigational agents targeting KRAS G12C are currently in clinical trials.
