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Roche Licenses Rights to Develop Assay, Companion Dx for EGFR Mutations

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Roche today announced agreements to develop a diagnostic assay for the detection of epidermal growth-factor receptor mutations and a PCR-based companion diagnostic test to identify patients with non-small cell lung cancer with EGFR-activating mutations.

In separate agreements, Roche has obtained a worldwide sub-license from Genzyme to develop the EGFR assay, and will collaborate with OSI Pharmaceuticals to develop the companion diagnostic.

Financial and other terms of the deals were not disclosed.

The companion diagnostic will run on Roche's cobas 4800 system and will test for EGFR activating mutations, allowing physicians to customize the use of Tarceva (erlotinib) for patients with advanced NSCLC, Daniel O'Day, head of Roche's Diagnostics Division, said in a statement.

While Tarceva has been shown to have benefits for a broad range of NSCLC patients, tumors with EGFR-activating mutations have been demonstrated to be especially sensitive to Tarceva, Roche said.

Tarceva is marketed by Genentech and OSI Pharmaceuticals in the US. Roche markets it elsewhere. It is the only EGFR inhibitor approved by the US Food and Drug Administration and the European Medicines Agency for use in maintenance and second-line treatment settings for patients with advanced or metastatic NSCLC with and without EGFR-activating mutations.

Roche has applied to the EMA to extend the current label for Tarceva to include first-line treatment of patients with advanced NSCLC harboring EGFR-activating mutations, the company said.