Description
The therascreen KRAS RGQ PCR Kit is a real-time, qualitative in vitro diagnostic test for the detection of 7 somatic mutations in the KRAS oncogene using a sample of DNA extracted from formalin-fixed, paraffin-embedded (FPPE) non-small cell lung cancer (NSCLC) tissue and colorectal cancer (CRC) tissue. Non-small cell lung cancer The therascreen KRAS RGQ PCR Kit is an FDA-approved companion diagnostic (CDx) PCR test intended to aid in the identification of NSCLC patients for treatment with LUMAKRAS (sotorasib) or KRAZATI (adagrasib) based on a KRAS G12C Mutation Detected result. Colorectal cancer The therascreen KRAS RGQ PCR Kit is an FDA-approved companion diagnostic (CDx) PCR test intended to aid in the identification of CRC patients for treatment with KRAZATI (adagrasib) in combination with ERBITUX (cetuximab) or LUMAKRAS in combination with Vectibix (panitumumab) based on a KRAS G12C Mutation Detected result. The kit is also an FDA-approved CDx test to aid in the selection of CRC patients who may be eligible for treatment with ERBITUX (cetuximab) or Vectibix (panitumumab) monotherapy, based on a KRAS No Mutation Detected test result.
Full clinical trial data supporting the use of the therascreen RGQ PCR Kit as a CDx test in NSCLC and CRC can be found here.
The therascreen KRAS RGQ PCR Kit is comprised of 8 separate PCR amplification reactions: 7 mutation‑specific reactions in codons 12 and 13 of exon 2 of the KRAS oncogene and a wild‑type control in exon 4. Each mutation-specific reaction mix uses an amplification refractory mutation system (ARMS) primer to selectively amplify mutated DNA and then a Scorpions primer to detect the amplification product. If both the run controls and the sample results are valid, the therascreen KRAS RGQ PCR Kit qualitatively determines the mutation status of the DNA samples and reports if the sample contains one or more mutations.
The simple and straightforward testing workflow begins with manual DNA extraction from FFPE NSCLC or CRC tumor tissue using the QIAamp DSP DNA FFPE Tissue Kit, followed by sensitive real-time PCR on the Rotor-Gene Q MDx (US) instrument. Rotor-Gene Q software rapidly and accurately determines mutations and reports results, informing the system operator if one or more of the 7 mutations detected by the kit are present. The assay can be completed in ~8 hours, providing next-day results.
