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Roche EGFR Mutation Test Approved in Canada

NEW YORK (GenomeWeb) – Roche Diagnostic Canada said on Tuesday that Health Canada has approved the Cobas EGFR Mutation Test v2 for marketing in that country. 

The oncology assay is the first from Roche using either plasma or tumor tissue samples and identifies 42 mutations in the epidermal growth factor receptor gene, which the firm said is the most of any in vitro diagnostic on the market. It added that the assay can also be used to help select appropriate patients with non-small cell lung cancer for therapy with an EGFR tyrosine kinase inhibitor. 

The assay includes expanded mutation coverage of the EGFR gene in DNA derived from tumor tissue and liquid biopsy and can be used to select NSCLC patients who harbor a T790M mutation for targeted treatment, as well as NSCLC patients with exon 19 deletions or L858 mutations. 

The US Food and Drug Administration approved Roche's test in 2015 as a companion diagnostic for AstraZeneca's Tagrisso (osimertinib) for NSCLC patients. Last  June, the agency approved the test to detect EGFR mutations associated with NSCLC in blood. Three months later, the FDA expanded the labeling for the test as a companion diagnostic for analyzing plasma samples from NSCLC patients who are considering treatment with Tagrisso.