Cobas EGFR Mutation test (Roche) receives CE mark for NSCLC testing

The Cobas EGFR Mutation Test, from Roche, is now CE marked for commercial availability in Europe and other countries that recognise CE mark. The Cobas EGFR Mutation Test is a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who harbour mutations in the EGFR (epidermal growth factor receptor) gene and who may benefit from treatment with anti-EGFR tyrosine kinase inhibitors such as Roche�s Tarceva (erlotinib). Tarceva, an oral EGFR inhibitor, was approved by the European Commission in September as first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR activating mutations. The Cobas EGFR Mutation Test rapidly detects 41 mutations across four different exons of the EGFR gene from a single section of the patient�s tumor and provides accurate mutation detection with a higher degree of sensitivity compared to Sanger sequencing, the most commonly used method for mutation detection. It delivers test results within an 8 hour period. The test runs on the Cobas 4800 System.