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KRAS Gene Mutation Analysis, IVD

KRAS Gene Mutation Analysis, Colorectal Cancer (CRC)
KRAS Gene Mutation Analysis, IVD
CPT: 81275; 88381
Updated on 06/9/2021
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Special Instructions

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


Expected Turnaround Time

5 - 7 days


Related Documents

For more information, please view the literature below.

K-ras Mutation Analysis


    Specimen Requirements


    Specimen

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

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

    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


    Test Details


    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.

    This KRAS assay is a real-time qualitative PCR test performed on the Rotor-Gene Q MDx instrument for the detection of the seven most common somatic mutations in the human KRAS oncogene, using DNA extracted from formalin-fixed paraffin-embedded (FFPE), colorectal cancer (CRC) tissue. This assay is intended to aid in the identification of CRC patients for treatment with cetuximab (Erbitux®), based on a KRAS "no mutation detected" test result. The presence of these mutations correlates with a lack of response for certain EGFR inhibitor cancer therapies in patients with metastatic colorectal cancer.

    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.


    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.

    The KRAS test is designed to detect seven mutations in codons 12 and 13 of the KRAS gene. These seven mutations account for >97% of all reported KRAS mutations in CRC patients. 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.

    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.


    Methodology

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


    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
    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.
    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.
    Qiagen Therascreen KRAS RGQ PCR Kit Instructions for Use (Handbook), 07/2012.
    Schuch G, Kobold S, Bokemeyer C. Evolving role of cetuximab in the treatment of colorectal cancer. Cancer Manag Res. 2009 Jul 23; 1:79-88
    Tejpar S, Celik I, Schlichting M, et al. 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.
    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, CRC 480876 K-ras Mutation Analysis Result 21702-6
    480875 KRAS Mutation Analysis, CRC 480877 Block Number: N/A
    480875 KRAS Mutation Analysis, CRC 480903 Microdissection Performed 8100-0
    480875 KRAS Mutation Analysis, CRC 480907 Nucleotide Change: 48004-6
    480875 KRAS Mutation Analysis, CRC 480937 Amino Acid Change: 48005-3
    480875 KRAS Mutation Analysis, CRC 480908 Background: 21703-4
    480875 KRAS Mutation Analysis, CRC 480938 Director Review: 72486-4

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