K-ras Gene Mutation Detection

Test Code

480090

CPT Codes
81275

Preferred Specimen

"Formalin-fixed, paraffin-embedded (FFPE) tissue. Send five precut unstained slides from paraffin block in 10-µM sections and an H&E reference slide or formalin-fixed, paraffin-embedded tissue block containing =50% tumor.
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Minimum Volume

"2 mm x 2 mm tumor area
"

Instructions

"Maintain blocks and slides at room temperature.
Provide five unstained slides and one H&E stained slide at 10 µM or tissue block
Please provide a copy of the pathology report. Please 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 insufficient tumor tissue or 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 provided tumor tissue should be composed of =50% tumor cells for accurate test interpretation. Preparation of DNA from tissue samples is dependent on the quality of the specimen provided. Inadequate DNA extraction may occur in a significant number of paraffin-embedded samples. The methods used in this assay are highly selective and, depending on the total amount of DNA present, can detect approximately 1% of mutant in a background of wild-type genomic DNA. The assay has a limit of detection of between five and ten copies
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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.