The therascreen EGFR kit is an in vitro diagnostic test for the detection of exon 19 deletions and exons 20 and 21 substitutions (T790M and L858R respectively) in the EGFR gene and will provide a qualitative assessment of the mutation status. Results are intended to aid the clinician in identifying patients with non-small cell lung cancer (NSCLC) who may benefit from treatment with IRESSA (gefitinib), from cell-free DNA (cfDNA) extracted from plasma sample when a tissue sample cannot be evaluated. The kit provides all necessary reagents, optimized for rapid and sensitive detection of a low percentage of mutant cfDNA in a background of wild-type cfDNA. ARMS PCR technology combined with the Scorpions detection technology provides exceptionally high sensitivity and specificity for the detection of specific mutations.

The method used is highly selective and, depending on the total amount of cfDNA present, enable detection of a low percentage of mutant in a background of wild-type cfDNA.

Source