K-ras Gene Mutation Detection With Reflex to BRAF Gene Mutation Detection

Test Code
480360


CPT Codes
81275

Preferred Specimen
"Formalin-fixed, paraffin-embedded tissue (FFPE)
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Minimum Volume
"2 mm x 2 mm tumor area
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Instructions
"Maintain blocks and slides at room temperature
Please provide five unstained slides and one H&E stained slide at 10 µM or a 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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Methodology
"Amplification refractory mutation system (ARMS) and real-time polymerase chain reaction 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 upon the quality of the provided specimen. 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 assays have limits of detection of between 5 and 10 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.