KRAS Gene Mutation Analysis, IVD
Also known as: therascreen KRAS RGQ PCR Kit
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
The assay detects mutations that account for more than 97% of all KRAS mutations in colorectal cancer (CRC) patients and estimates that the KRAS G12C mutation exists in around 13% of NSCLC cases. Samples that result in 'no mutation detected' may still contain undetected KRAS mutations. Detection is dependent on sample integrity and DNA quantity, able to identify roughly 1-5% mutant DNA in wild-type genomic DNA.
Methodology
PCR-based (qPCR)
Biomarkers
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
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