Roche has received CE mark for its cobas EGFR Mutation Test, a companion diagnostic to identify patients with non-small cell lung cancer who harbor mutations in the EGFR gene and who may benefit from treatment with anti-EGFR tyrosine kinase inhibitors.

The Swiss healthcare firm claims that the new test rapidly detects 41 mutations across four different exons of the epidermal growth factor receptor (EGFR) gene from a single section of the patient’s tumor.

Daniel O’Day, COO of Roche Diagnostics, said: “Our new EGFR test will help physicians to directly determine the appropriate course of treatment for the individual patient. Patients with this genetically distinct form of lung cancer derive great benefit when EGFR inhibitors are used as initial treatment.  The cobas EGFR test together with other companion tests already launched this year greatly illustrates our strength to enable and support personalized treatment approaches.”

The European Commission (EC) has approved Roche’s Tarceva (erlotinib), an EGFR inhibitor, in September 2011 as first-line monotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.