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KRAS Gene Extended Mutation Analysis

Test Number 570203
Test number copied
CPT

81275; 81276; 88381

Test Details

Methodology

SNaPshot Multiplex PCR (primer extension-based method)

Result Turnaround Time

5 - 7 days

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.

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.

Specimen Requirements

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 Food and Drug Administration.

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.

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
570203 KRAS Mutation Analysis 570204 Referring Physician 18781-5
570203 KRAS Mutation Analysis 570205 Treating Physician 18781-5
570203 KRAS Mutation Analysis 570206 Body Site 39111-0
570203 KRAS Mutation Analysis 570207 Client Specimen ID N/A
570203 KRAS Mutation Analysis 570208 Specimen(s) Received 31208-2
570203 KRAS Mutation Analysis 570209 Clinical Data 55752-0
570203 KRAS Mutation Analysis 570210 Results: 50397-9
570203 KRAS Mutation Analysis 570211 Interpretation 62365-2
570203 KRAS Mutation Analysis 570212 Analytical Results 21702-6
570203 KRAS Mutation Analysis 570213 Comments 77202-0
570203 KRAS Mutation Analysis 570214 Methodology: 49549-9
570203 KRAS Mutation Analysis 570215 References: 75608-0
570203 KRAS Mutation Analysis 570216 Electronically Signed by 19131-5
570203 KRAS Mutation Analysis 570217 Disclaimer N/A
570203 KRAS Mutation Analysis 570218 PDF 11502-2
570203 KRAS Mutation Analysis 570219 Bill Code Entry Hold N/A
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570204
Result Code NameReferring Physician
UofM
Result LOINC18781-5
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570205
Result Code NameTreating Physician
UofM
Result LOINC18781-5
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570206
Result Code NameBody Site
UofM
Result LOINC39111-0
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570207
Result Code NameClient Specimen ID
UofM
Result LOINCN/A
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570208
Result Code NameSpecimen(s) Received
UofM
Result LOINC31208-2
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570209
Result Code NameClinical Data
UofM
Result LOINC55752-0
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570210
Result Code NameResults:
UofM
Result LOINC50397-9
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570211
Result Code NameInterpretation
UofM
Result LOINC62365-2
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570212
Result Code NameAnalytical Results
UofM
Result LOINC21702-6
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570213
Result Code NameComments
UofM
Result LOINC77202-0
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570214
Result Code NameMethodology:
UofM
Result LOINC49549-9
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570215
Result Code NameReferences:
UofM
Result LOINC75608-0
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570216
Result Code NameElectronically Signed by
UofM
Result LOINC19131-5
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570217
Result Code NameDisclaimer
UofM
Result LOINCN/A
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570218
Result Code NamePDF
UofM
Result LOINC11502-2
Order Code570203
Order Code NameKRAS Mutation Analysis
Order Loinc
Result Code570219
Result Code NameBill Code Entry Hold
UofM
Result LOINCN/A
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057203 KRAS Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057203
Order NameKRAS Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057203 KRAS Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057203
Order NameKRAS Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057203 KRAS Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057203
Order NameKRAS Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057203 KRAS Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057203
Order NameKRAS Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057203 KRAS Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057203
Order NameKRAS Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057203 KRAS Mutation Analysis (B) 000000 PDF 11526-1
Reflex 1
Order Code057203
Order NameKRAS Mutation Analysis (B)
Result Code000000
Result NamePDF
UofM
Result LOINC11526-1