Special Instructions
Provide a copy of the pathology report; the KRAS test will be delayed if the pathology report is not received. Direct any questions regarding this test to customer service at 800-345-4363.
Expected Turnaround Time
5 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Specimen Requirements
Specimen
Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides.
Volume
Formalin-fixed, paraffin-embedded tissue block or four unstained slides and one matching H&E-stained slide at 5 µM.
Minimum Volume
Two unstained slides and one matching H&E-stained slide at 5 μM. Samples with >4 mm² and ≥50% tumor content are preferred.
Container
FFPE tissue blocks or slides.
Storage Instructions
Maintain blocks and slides at room temperature.
Causes for Rejection
Tumor block containing no tumor tissue; broken or stained slides
Test Details
Use
KRAS is a guanosine triphosphate (GTP) binding protein involved in downstream receptor signaling, which is critical for cell proliferation, survival, and differentiation. Mutations in the KRAS oncogene are frequently found in human cancers. They are common in pancreatic, colorectal, lung, gallbladder, bile duct, and thyroid cancer. This assay will detect KRAS mutations in exons 2, 3, and 4, allowing the determination of drug response.
Limitations
This assay is able to detect 5% mutation in a background of wild-type DNA.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).
Methodology
SNaPshot Multiplex PCR (primer extension-based method)
References
Bokemeyer C, Van Cutsem E, Rougier P, et al. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: Pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer. 2012 Jul; 48(10):1466-1475. 22446022
Douillard JY, Siena A, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: The PRIME study. J Clin Oncol. 2010 Nov 1; 28(31):4697-4705. 20921465
Karachaliou N, Mayo C, Costa C, et al. KRAS mutations in lung cancer. Clin Lung Cancer. 2013 May; 14(3):205-214. 23122493
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer v2.2015. Fort Washington, Pa: NCCN; 2015.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer v3.2015. Fort Washington, Pa: NCCN; 2015.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Rectal Cancer v2.2015. Fort Washington, Pa: NCCN; 2015.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 481075 | KRAS Extended Analysis | 481061 | KRAS Mutation Analysis Result | 21702-6 | ||
| 481075 | KRAS Extended Analysis | 481062 | Indications: | 42349-1 | ||
| 481075 | KRAS Extended Analysis | 481063 | Specimen Location: | N/A | ||
| 481075 | KRAS Extended Analysis | 481064 | Specimen Type: | 31208-2 | ||
| 481075 | KRAS Extended Analysis | 481066 | Block Number: | 57723-9 | ||
| 481075 | KRAS Extended Analysis | 481072 | Nucleotide Change: | 48004-6 | ||
| 481075 | KRAS Extended Analysis | 481073 | Amino Acid Change: | 48005-3 | ||
| 481075 | KRAS Extended Analysis | 481074 | Director Review: | 72486-4 | ||
| 481075 | KRAS Extended Analysis | 481067 | Background: | 21703-4 | ||
| 481075 | KRAS Extended Analysis | 481506 | Methodology: | 49549-9 | ||
| 481075 | KRAS Extended Analysis | 481071 | References: | 75608-0 | ||
| 481075 | KRAS Extended Analysis | 480903 | Microdissection Performed | 8100-0 | ||
| 481075 | KRAS Extended Analysis | 481133 | Referring Physician | 18781-5 | ||
| 481075 | KRAS Extended Analysis | 481134 | Treating Physician | 18781-5 | ||
| 481075 | KRAS Extended Analysis | 481135 | Body Site | 39111-0 | ||
| 481075 | KRAS Extended Analysis | 481136 | Client Specimen ID | N/A | ||
| 481075 | KRAS Extended Analysis | 481137 | Specimens Received | 31208-2 | ||
| 481075 | KRAS Extended Analysis | 481138 | Clinical Data | 55752-0 | ||
| 481075 | KRAS Extended Analysis | 481140 | Interpretation | 62365-2 | ||
| 481075 | KRAS Extended Analysis | 481141 | Analytical Results | 21702-6 | ||
| 481075 | KRAS Extended Analysis | 481142 | Comments | 77202-0 | ||
| 481075 | KRAS Extended Analysis | 481143 | Signed By | 19139-5 | ||
| 481075 | KRAS Extended Analysis | 481144 | Disclaimers | N/A | ||
| 481075 | KRAS Extended Analysis | 481145 | 51969-4 |
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