Genzyme’s KRAS Mutation Analysis provides additional guidance in therapeutic treatment decisions for patients with non-small cell lung cancer (NSCLC).
Mutations in the KRAS gene, a known downstream signaling molecule in the EGFR signaling pathway, have been described in approximately 15-30% of lung adenocarcinoma.
Recent studies have found mutations in the KRAS gene to be associated with a poor prognosis. Studies have also found KRAS mutations more frequent in patients who show limited clinical response or develop disease progression with targeted tyrosine kinase inhibitor (TKI) treatments. As a result, determining the KRAS mutational status of a tumor may guide therapeutic decision making for patients with NSCLC.
The molecular diagnostic procedure incorporates allele-specific primer extensions for detecting mutations in codons 12 and 13 of the KRAS gene.
Please Note: Include a copy of the original pathology report.
Information Sheet - KRAS Mutation Analysis - NSCLC (PDF)
CPT Codes:
83890(1), 83892(3), 83898(1), 83907(1), 83909(2), 83912(1), 83914(4), 88381(1)
Specimen Requirements:
3 Options
Lung Tumor (and metastases) Specimen Options**
Option 1 - Formalin-fixed, Paraffin-embedded Block with Corresponding H&E slide (preferred specimen type):
- Tissues should be well-fixed in formalin. If an alternative fixative is used, it should be noted on the requisition.
- Store specimen at room temperature (20-23.5°C).
- Use cold pack for transport. Be sure cold pack is not in direct contact with specimen during transport.
Option 2 - Unstained Slides:
- Send all slides within 5-7 days of cutting.
- Minimum of 4 slides (plus 1 H&E) or 5 slides (w/o H&E).
- Pre-cut slides from paraffin block in 7 micron sections.
- Air dry. Do not oven dry.
- Store specimen at room temperature (20-23.5°C).
Option 3 - Fresh Snap Frozen Biopsy:
- Fresh tissue snap frozen at -20°C.
- Store at -20°C.
- Ship on minimum of 10 lbs. dry ice.
**Decalcified samples and Bouin’s, B-5, or any fixative containing heavy metals (i.e., zinc) are incompatible with sensitive DNA-based methodologies and are not acceptable sample types for this test.
Please Note: To submit a sample to run in our comprehensive NSCLC profile (e.g., EGFR mutation, EGFR FISH and KRAS mutation analyses), please contact our Client Services Department for complete specimen requirement submission details.
Turnaround Time:
8-10 days
Client Services:
Oncology/Pathology
800-447-5816
Specimen Services/Pickup:
877-246-1226