Lung Cancer Diagnostic Gene Mutation Test Approved

A companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of non-small-cell lung cancers (NSCLC), has been approved.

NSCLC is the most common form of lung cancer, accounting for about 85% of cases and patients with such genetic mutations generally benefit from treatment with an anti-EGFR tyrosine kinase inhibitor.


The cobas EGFR Mutation Test is manufactured by the Roche Molecular Systems (Pleasanton, CA, USA) and will be used as a companion diagnostic for the drug Tarceva, as a form of first-line treatment for patients with NSCLC whose cancers have spread to other parts of the body. This is the first US Food and Drug Administration (FDA; Silver Spring, MD, USA) approved companion diagnostic that detects EGFR gene mutations.

The safety and effectiveness of the cobas EGFR Mutation Test was established with clinical data showing that, on average, NSCLC patients with specific types of EGFR mutations, the exon 19 deletions or the exon 21 L858R substitution mutations, lived without their disease progressing for 10.4 months when they received Tarceva treatment. This was compared to those who received a standard two-drug chemotherapy regimen who lived for 5.4 month before disease progression. Investigators used tumor samples from the clinical trial to validate the test’s use in this patient population.

Alberto Gutierrez, PhD., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said: "The approval of the cobas EGFR Mutation Test will allow physicians to identify non-small-cell lung cancer patients who are candidates for receiving Tarceva as first line therapy. Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient."

According to the US National Cancer Institute (Bethesda, MD, USA), lung cancer is currently one of the leading causes of cancer-related deaths, with an anticipated 228,190 new cases of the cancer this year alone, and approximately 159,480 deaths. Each year in the US, lung cancer kills more individuals than prostate, colon, and breast cancers combined.

Related Links:
Roche Molecular Systems
US Food and Drug Administration
US National Cancer Institute