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KRAS Mutation testing

Item Value
Approval req'd? No
Available Stat? No
Test code
Performed by Clinical Cancer Genomics Laboratory (CCGL)
In House Availability Test performed once a week, with DNA extraction set up on Mondays and Wednesdays, test run on Tuesday or Wednesday, day shift only
Method PCR and Sequencing
Collection Instructions Blocks selected for KRAS mutation testing must contain tumor tissue. Areas of tumor must contain at least 50% tumor cells. The lab can remove adjacent non-tumor tissue, so the entire slide does not need 50% tumor cells, just the area with tumor. Contact the laboratory (415-514-1035, AGCLab@ucsf.edu) if the specimen suitability is uncertain. Label slides with pathology case number and block identification.

Complete an Clinical Cancer Genomics Laboratory (CCGL) requisition and submit it with samples.

Click here for requisition form
Container type
Sample type Formalin-fixed, paraffin-embedded tissue. Tissue block or unstained slides. If sending unstained slides, we require five (5) 10-micron tissue sections on uncharged glass slides. One adjacent H&E stained slide should be included. Cytology smears may also be used for testing if there is sufficient tumor present. Contact the laboratory (415-502-3252) if testing on a cytology smear or other sample types is desired.
UCSF Rejection Criteria All required slides not included. Insufficient tumor tissue present on slide as determined by pathologist. Slides not labeled or not accompanied by completed requisition form (if not ordered directly through Department of Pathology).
Processing notes Contact CCGL at 415-502-3252 and inform them that a sample is available for pickup and your location.
Normal range Negative for KRAS mutations at codons 12 and 13.
Synonyms K-RAS
Stability Formalin-fixed, paraffin-embedded tissues are stable indefinitely at room temperature
Turn around times 7-10 days
Additional information An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

KRAS Mutation Testing with the shifted termination assay utilizes PCR amplification of the region surrounding codons 12 and 13 from genomic DNA and primer extension reactions followed by capillary electrophoresis fragment analysis. This assay is clinically validated for the detection of wild type and the detection of mutations G12V, G12D, G12A, G12C, G12S, G13R, G13C, and G13D. If additional mutations are seen, the samples will be confirmed by an additional assay.

Codons 12 and 13 of the KRAS gene are analyzed for the most common mutations described at these sites in lung and colorectal cancers. Mutations of these codons have been shown to be predictive of resistance to EGFR-directed therapy in patients with non-small cell lung cancer and metastatic colorectal cancer.

Results of this test should be correlated with the patient's other clinical and laboratory information. This assay is not intended to test for KRAS mutations outside of codons 12 and 13.

The test was validated by the UCSF Clinical Cancer Genomics Laboratory (CCGL) to confirm performance characteristics, in compliance with current guidelines for clinical implementation
CPT coding 81275
LDT or Mod FDA? Yes
Last Updated 10/1/2015 8:52:38 AM
Entry Number 1300
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