KRAS Mutation Analysis in Colorectal Cancer

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 30-60% 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.

CPT Codes:

83890, 83892(2), 83898, 83904(2), 83907, 83909(2), 83912

Please Note: Include a copy of the original pathology report.

Specimen Requirements:

Colorectal Tumor Specimens* (and metastases)

1. Formalin-fixed, Paraffin-embedded Block with Corresponding H&E (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.

2. Unstained Slides:

• Send all slides within 5-7 days of cutting.
• Minimum of 4 slides (w/ 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).

3. Fresh Snap Frozen Biopsy:

• Fresh tissue snap frozen at -20°C.
• Store at -20°C.
• Ship on minimum of 10 lbs. dry ice.

* We will accept core needle biopsies, FNAs and pleural effusions; however, the smaller amount of tissue usually present in these specimens can lower the success rate of the assay.

Turnaround Time:

8-10 days