FDA-approved for in vitro diagnostic use with GILOTRIF or IRESSA
Ready-to-use system with simple workflow
Specific and sensitive due to ARMS and Scorpions PCR technologies
Product Details
The therascreen EGFR RGQ PCR Kit is an FDA-approved, qualitative real-time PCR assay for the detection of specific mutations in the EGFR oncogene. The kit provides reagents optimized for rapid and sensitive detection of 21 somatic mutations using the QIAamp DSP DNA FFPE Tissue Kit and the Rotor-Gene Q MDx instrument.
Principle
The therascreen EGFR RGQ PCR Kit is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom GILOTRIF (afatinib) or IRESSA (gefitinib) EGFR tyrosine kinase inhibitors (TKIs) are indicated. Safety and efficacy of GILOTRIF (afatinib) has not been established in patients whose tumors have exon 20 insertions and T790M mutations. Safety and efficacy of IRESSA (gefitinib) has not been established in patients whose tumors have L861Q, G719X, S768I, exon 20 insertions and T790M mutations. These EGFR mutations are also detected by the therascreen EGFR RGQ PCR Kit.
Allele- or mutation-specific amplification is achieved by ARMS (Amplification Refractory Mutation System). ARMS primers preferentially anneal with DNA containing the mutation and allow Taq DNA polymerase to initiate PCR, effectively distinguishing between a match