KRAS Mutation Analysis (PCR)
Molecular · Dermatology
The KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of seven somatic mutations in codons 12 and 13 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients for whom treatment with Erbitux® (cetuximab) or with Vectibix® (panitumumab) may be indicated based on a no mutation detected result.
Table of Contents
Assay Description
The KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of seven somatic mutations in codons 12 and 13 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients for whom treatment with Erbitux® (cetuximab) or with Vectibix® (panitumumab) may be indicated based on a no mutation detected result.
Specimen Requirements
•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
Storage and Transport
•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
Specimen Rejection Criteria
All specimens must be submitted according to the test directory instructions. Before submitting specimen, please carefully review specimen requirements.
Listed below are possible causes for delays in specimen processing or possible specimen rejections or cancellations:
- No patient identification on requisition form
- No patient identification on specimen container or slides
- No referring provider
- No account information provided
- No test ordered on requisition
- No specimen source provided
- Inappropriate specimen type
- Insufficient volume for analysis
- Inappropriate specimen container
- Improper specimen transport
- Specimen leaked in transport
- Specimen submitted in incorrect or expired transport media
- Slides broken beyond repair on receipt
- Conflict between patient name on specimen and requisition form
- Specimen not properly preserved
- Sample containing a needle
- Obviously damaged samples
- Samples diagnosed more than 5 years prior to testing
- Samples containing only melanoma in situ
A representative from Client Services will attempt to contact your office to resolve specimen problems. Additional documentation may be requested from your office to be returned by fax. In the event that resolution is not possible, the specimen may be returned to your office.
Turn Around Time (TAT)
14 days from receipt of specimen.
CPT Codes*
Unlisted chemistry code: 84999