K-ras Gene Mutation Analysis, Colorectal Cancer (CRC)

Test Code
480875


CPT Codes
81275

Preferred Specimen
"Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides from colorectal cancer
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Minimum Volume
"Two unstained slides and one matching H&E-stained slide at 5 µM. Samples with >4 mm2 and =20% tumor content are preferred.
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Instructions
"Maintain specimen at room temperature.
Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363.
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Transport Container
"Slides, blocks
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Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
"Tumor block containing no tumor tissue; tumor fixed in a heavy metal fixative; broken or stained slides
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Methodology
"Amplification refractory mutation system (ARMS) and real-time polymerase chain reaction (PCR) using Scorpions™ technology "

Limitations
"The K-ras test is designed to detect seven mutations in codons 12 and 13 of the K-ras gene. These seven mutations account for >97% of all reported K-ras mutations in CRC patients. Samples with results reported as ""no mutation detected"" may harbor K-ras 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.
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The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.