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KRAS Mutation Analysis in Colorectal Cancer (CRC)

Genzyme’s KRAS Mutation Analysis provides additional guidance in therapeutic treatment decisions for patients with colorectal cancer (CRC).

Mutations in the KRAS gene, a known downstream signaling molecule in the EGFR signaling pathway, have been described in approximately 30-50% of colorectal carcinomas.

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 to targeted anti-epidermal growth factor receptor (anti-EGFR) therapies. As a result, determining the KRAS mutational status of a tumor may guide therapeutic decision making for patients with CRC.

The molecular diagnostic procedure incorporates allele-specific primer extensions for detecting mutations in codons 12 and 13 of the KRAS gene.

Information Sheet - KRAS Mutation Analysis - CRC (PDF)

CPT Codes:

83890(1), 83892(3), 83898(1), 83907(1), 83909(2), 83912(1), 83914(4), 88381(1)


Specimen Requirements:

3 Options

Colorectal 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.

*Please Note: 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.

Turnaround Time:

8-10 days


Client Services: Oncology/Pathology   800-447-5816

Specimen Services/Pickup:  877-246-1226