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KRAS Gene Mutation Analysis, IVD

Test Number 480875
Test number copied
CPT 81275; 88381

Test Details

Methodology

Amplification refractory mutation system (ARMS) and real-time polymerase chain reaction (PCR) using Scorpions™ technology

Result 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 Documents

For more information, please view the literature below.

K-ras Mutation Analysis

Use

The therascreen KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx (US) instrument for the detection of 7 somatic mutations in the human KRAS oncogene using DNA extracted from formalin fixed paraffin embedded (FFPE) colorectal cancer (CRC) tissue and non-small cell lung cancer (NSCLC) tissue. The therascreen KRAS RGQ PCR Kit is intended to aid in the identification of CRC patients for treatment with Erbitux® (cetuximab) or with Vectibix® (panitumumab) based on a KRAS No Mutation Detected test result. The therascreen KRAS RGQ PCR Kit is also intended to aid in the identification of NSCLC patients for treatment with LUMAKRAS™ (sotorasib) based on a KRAS G12C Mutation Detected result.

Special Instructions

Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363.

Limitations

Based on data in the COSMIC database (2012 v59), the seven mutations detected by the KRAS Kit account for >97% of all reported KRAS mutations in CRC patients. The KRAS G12C mutation is estimated to be present in around 13% of NSCLC cases.

Samples with results reported as "no mutation detected" may harbor KRAS mutations that are not detected by the assay.

Detection of mutation is dependent on sample integrity and the amount of amplifiable DNA present in the specimen. The methods used in this assay are highly selective and, depending on the total amount of DNA present, can detect approximately 1% to 5% of mutant DNA in a background of wild-type genomic DNA.

Specimen Requirements

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides from colorectal cancer or NSCLC

Volume

Four unstained slides and one matching H&E-stained slide at 5 μM or formalin-fixed, paraffin-embedded tissue block

Minimum Volume

Two unstained slides and one matching H&E-stained slide at 5 μM. Samples with >4 mm² and ≥20% tumor content are preferred.

Container

Slides, blocks

Storage Instructions

Maintain specimen at room temperature up to 4 weeks at 15-30°C.

Causes for Rejection

Tumor block containing no tumor tissue; tumor fixed in a heavy metal fixative; broken or stained slides

References

Arbour KC, Jordan E, Kim HR et al. Effects of Co-occurring Genomic Alterations on Outcomes in Patients with KRAS-Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2018 Jan 15;24(2):334-340.29089357
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 randomized clinical trials. Eur J Cancer. 2012 Jul;48(10):1466-1475.22446022
Catalogue of Somatic Mutations in Cancer (COSMIC). COSMIC web site: www.sanger.ac.uk/genetics/CGP/cosmic. Updated May 28, 2021. Accessed June 2021.
Di Fiore F, Blanchard F, Charbonnier F, et al. Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy. Br J Cancer. 2007 Apr 23;96(8):1166-1169.17375050
Qiagen Therascreen KRAS RGQ PCR Kit Instructions for Use (Handbook), June 2021.
Schuch G, Kobold S, Bokemeyer C. Evolving role of cetuximab in the treatment of colorectal cancer. Cancer Manag Res. 2009 Jul 23;1:79-8821188126
Tejpar S, Celik I, Schlichting M, Sartorius U, Bokemeyer C, Van Cutsem E. Association of KRAS G13D tumor mutations with outcome in patients with a metastatic colorectal cancer treated with first-line chemotherapy with or without cetuximab. J Clin Oncol. 2012 Oct 10;30(29):3570-3577.22734028

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
480875 KRAS Mutation Analysis, IVD 480876 K-ras Mutation Analysis Result 21702-6
480875 KRAS Mutation Analysis, IVD 480877 Block Number: 57723-9
480875 KRAS Mutation Analysis, IVD 480903 Microdissection Performed 8100-0
480875 KRAS Mutation Analysis, IVD 480907 Nucleotide Change: 48004-6
480875 KRAS Mutation Analysis, IVD 480937 Amino Acid Change: 48005-3
480875 KRAS Mutation Analysis, IVD 480908 Background: 21703-4
480875 KRAS Mutation Analysis, IVD 480938 Director Review: 72486-4
Order Code480875
Order Code NameKRAS Mutation Analysis, IVD
Order Loinc
Result Code480876
Result Code NameK-ras Mutation Analysis Result
UofM
Result LOINC21702-6
Order Code480875
Order Code NameKRAS Mutation Analysis, IVD
Order Loinc
Result Code480877
Result Code NameBlock Number:
UofM
Result LOINC57723-9
Order Code480875
Order Code NameKRAS Mutation Analysis, IVD
Order Loinc
Result Code480903
Result Code NameMicrodissection Performed
UofM
Result LOINC8100-0
Order Code480875
Order Code NameKRAS Mutation Analysis, IVD
Order Loinc
Result Code480907
Result Code NameNucleotide Change:
UofM
Result LOINC48004-6
Order Code480875
Order Code NameKRAS Mutation Analysis, IVD
Order Loinc
Result Code480937
Result Code NameAmino Acid Change:
UofM
Result LOINC48005-3
Order Code480875
Order Code NameKRAS Mutation Analysis, IVD
Order Loinc
Result Code480908
Result Code NameBackground:
UofM
Result LOINC21703-4
Order Code480875
Order Code NameKRAS Mutation Analysis, IVD
Order Loinc
Result Code480938
Result Code NameDirector Review:
UofM
Result LOINC72486-4