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Roche's Cobas EGFR Assay Gets CE Mark

NEW YORK (GenomeWeb) – Roche today announced that the Cobas EGFR Mutation Test v2 has received CE marking and is commercially available in countries that accept the designation. 

The test is Roche's first that uses either plasma or tissue as a sample type, the firm said. It identifies 42 mutations in the epidermal growth factor receptor gene and can be used to help select patients with non-small lung cancer for treatment with an EGRF tyrosine kinase inhibitor. 

Roche recently submitted the assay for premarket approval with the US Food and Drug Administration as a companion diagnostic to AstraZeneca's NSCLC drug AZD9291.