Roche has received CE mark approval for its companion diagnostic cobas epidermal growth factor receptor (EGFR) Mutation Test to treat non-small cell lung cancer (NSLC).
The cobas EGFR Mutation Test is a real-time polymerase chain reaction-based diagnostic test which detects 41 mutations across EGFR gene’s exons 18, 19, 20 and 21.
The cobas EGFR Mutation Test is designed to identify NSLC patients who have mutations in their EGFR gene and who may benefit with the company’s anti-EGFR tyrosine kinase inhibitors – Tarceva (erlotinib).
Roche Diagnostics COO Daniel Day said their new EGFR test will help physicians to directly determine the appropriate course of treatment for the individual patient.
"Patients with this genetically distinct form of lung cancer derive great benefit when EGFR inhibitors are used as initial treatment," Day said.