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KRAS Gene Mutation Analysis, IVD

CPT 81275; 88381

Test Details

Cancer Type

Colorectal cancer (CRC), Lung, Non-small cell lung cancer

Technology Used


Turnaround Time

5 - 7 days


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.


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.


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

Related Documents

For more information, please view the literature below.

K-ras Mutation Analysis

    Specimen Requirements

    Information on collection, storage, and volume


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


    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.


    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