Assay is a companion diagnostic for EGFR tyroskine kinase inhibitors.

Roche’s  cobas EGFR Mutation Test received a CE mark. The regulatory stamp means the test will be commercially available as a companion diagnostic to identify non-small-cell lung cancer (NSCLC) patients with EGFR mutations who may benefit from anti-EGFR tyrosine kinase inhibitors.

Roche itself has a tyrosine kinase inhibitor for NSCLC, Tarceva. The drug was approved by the EC in September as first-line monotherapy in patients with locally advanced or metastatic NSCLC with EGFR-activating mutations.

Carried out on a section of tumor, the real-time PCR-based cobas EGFR Mutation Test detects 41 mutations across exons 18, 19, 20, and 21 of the EGFR gene. The firm claims the assay has a higher degree of sensitivity than Sanger sequencing and delivers test results within eight hours.

The cobas EGFR Muation Test is the third cobas oncology diagnostic to be granted a CE mark this year. It joins the cobas BRAF Mutation Test for metastatic melanoma and the cobas KRAS Mutation Test for advanced colorectal cancer. All assays are carried out on the cobas 4800 system v2.0. 

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