Swiss-based 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 that identifies 41 mutations across EGFR gene's exons 18, 19, 20 and 21.
The EGFR assay that runs on the cobas 4800 system will 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).
Tarceva is a once-daily, oral, non-chemotherapy treatment, designed to inhibit EGFR, a protein involved in the growth and development of cancers.
Roche Diagnostics COO Daniel O'Day said the new EGFR test would help health care providers to determine the appropriate course of treatment for individual patients.
"Patients with this genetically distinct form of lung cancer derive great benefit when EGFR inhibitors are used as initial treatment," he added.