The EGFR StripAssay detects the most important mutations/deletions/insertions in exons 18 through 21 of the Epidermal Growth Factor Receptor (EGFR) gene, [ex 18; G719C, G719S, G719A, ex 19; E746_A750del (2249del), E746_A750del (2250del), E746_T751delinsA, E746_S752delinsV, L747_A750delinsP, L747_T751delinsP, L747_T751del, L747_P753delinsS, L747_S752del, L747_E749del,ex 20; T790M, ex 21; L858R, L861Q]. It is capable of detecting mutations at a level of 1 percent in a background of wild-type EGFR.
The EGFR signalling pathway is a key factor for various cellular functions, such as proliferation and differentiation. EGFR mutations that lead to overexpression or overactivity have been associated with several types of cancer. The tyrosine kinase inhibitors erlotinib (Tarceva) and gefitinib (Iressa), which block the EGFR tyrosine kinase activity, have been successfully applied for the treatment of non-small cell lung cancer (NSCLC). Treatment, however, is only effective in patients carrying an EGFR-activating mutation. On the other hand, mutations such a T790M, confer resistance to tyrosine kinase inhibitor drugs. It was therefore recommended that the EGFR mutation status of tumors shall be assessed prior to start treatment.