Roche's Cobas EGFR mutation test

Roche's Cobas EGFR mutation test--Courtesy of Roche

In one of many wins for 2013, Roche's ($RHHBY) diagnostics arm nailed an FDA approval for its Cobas EGFR mutation test. The companion diagnostic is designed to work alongside Tarceva, a first-line drug that treats metastatic non-small cell lung cancer patients who have certain epidermal growth factor receptor-activating mutations. Cobas EGFR is also the first test of its kind targeted toward the specific EGFR mutations. Astellas Pharma and Roche's Genentech developed Tarceva, which won FDA approval as a first-line treatment after a previously limited OK to help patients who have failed at least one chemotherapy treatment.

Roche took a slow and steady path toward its May 2013 approval, focusing on 174 patients from February 2007 to January 2011. While it is the first out of the gate, Qiagen ($QGEN) has already followed suit, gaining approval in late summer for a companion diagnostic designed to go with a Boehringer Ingelheim drug that also targets EGFR lung cancer mutations.

Roche CMO Hal Barron noted previously in a statement that 10% to 30% of patients with non-small cell lung cancer have EGFR mutations.

For more:
Roche gains FDA sign-off on lung cancer companion Dx
Roche wins new targeted OK for Tarceva in EGFR-positive lung cancer

Roche's Cobas EGFR mutation test