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KRAS Gene Mutation Analysis, Colorectal Cancer (CRC)
This KRAS assay is a real-time qualitative PCR test performed on the Rotor-Gene Q MDx instrument for the detection of the seven most common somatic mutations in the human KRAS oncogene, using DNA extracted from formalin-fixed paraffin-embedded (FFPE), colorectal cancer (CRC) tissue. This assay is intended to aid in the identification of CRC patients for treatment with cetuximab (Erbitux®), based on a KRAS "no mutation detected" test result. The presence of these mutations correlates with a lack of response for certain EGFR inhibitor cancer therapies in patients with metastatic colorectal cancer.
The KRAS test is designed to detect seven mutations in codons 12 and 13 of the KRAS gene. These seven mutations account for >97% of all reported KRAS mutations in CRC patients. Samples with results reported as "no mutation detected" may harbor KRAS mutations that are not detected by the assay.
Detection of mutation is dependent on sample integrity and the amount of amplifiable DNA present in the specimen. The methods used in this assay are highly selective and, depending on the total amount of DNA present, can detect approximately 1% to 5% of mutant DNA in a background of wild-type genomic DNA.
Amplification refractory mutation system (ARMS) and real-time polymerase chain reaction (PCR) using Scorpions™ technology
Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides from colorectal cancer
Four unstained slides and one matching H&E-stained slide at 5 μM or formalin-fixed, paraffin-embedded tissue block
Two unstained slides and one matching H&E-stained slide at 5 μM. Samples with >4 mm² and ≥20% tumor content are preferred.
Causes for Rejection
Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363.
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|480875||KRAS Mutation Analysis, CRC||480876||K-ras Mutation Analysis Result||21702-6|
|480875||KRAS Mutation Analysis, CRC||480877||Block Number:||N/A|
|480875||KRAS Mutation Analysis, CRC||480903||Microdissection Performed||8100-0|
|480875||KRAS Mutation Analysis, CRC||480907||Nucleotide Change:||48004-6|
|480875||KRAS Mutation Analysis, CRC||480937||Amino Acid Change:||48005-3|
|480875||KRAS Mutation Analysis, CRC||480908||Background:||21703-4|
|480875||KRAS Mutation Analysis, CRC||480938||Director Review:||72486-4|
|480875||KRAS Mutation Analysis, CRC||511973||Putaway||N/A|