A new test may help lung cancer patient benefit from early, persoalized treatment option. The cobas EGFR Mutation Test, a real-time polymerase chain reaction-based diagnostic test that identifies 41 mutations across exons 18, 19, 20 and 21 of the EGFR gene using multiplex PCR chemistry developed by Roche Diagnostics, a division of F. Hoffmann-La Roche Ltd, is now CE marked for commercial availability in Europe and other countries that recognize CE mark.

The cobas EGFR Mutation Test is a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who harbor mutations in the EGFR (epidermal growth factor receptor) gene and who may benefit from treatment with anti-EGFR tyrosine kinase inhibitors such a erlotinib Tarceva?

First-line monotherapy
Erlotinib, a once-daily, non-chemotherapy, oral EGFR inhibitor, was approved by the European Commission in September as first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR activating mutations. The drug has been shown to potently inhibit EGFR, a protein involved in the growth and development of cancers.

Appropriate – personalized – treatment
?[The] new EGFR test will help physicians to directly determine the appropriate course of treatment for the individual patient,? said Daniel O?Day, COO of Roche Diagnostics. ?Patients with this genetically distinct form of lung cancer derive great benefit when EGFR inhibitors are used as initial treatment. The cobas EGFR test together with other companion tests already launched this year greatly illustrates our strength to enable and support personalised treatment approaches.?

EGFR activating mutations
It is estimated that 10-30% of patients with NSCLC have tumors with EGFR activating mutations which are highly responsive to EGFR inhibitors such as erlotinib [1]. Treatment with this medicine has been shown to more than triple the number of patients whose tumours shrink (response rate) and to nearly double the time patients live without their disease progressing (progression free survival ? PFS) compared to chemotherapy. [2,3]

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A number of international oncology organizations such as the European Society for Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recommend EGFR mutation testing for people with metastatic NSCLC.

Diagnostic test
Roche’s cobas EGFR Mutation Test rapidly detects 41 mutations across four different exons of the EGFR gene from a single section of the patient?s tumor. It provides automated analysis and reporting, accurate and reliable mutation detection with a higher degree of sensitivity compared to Sanger sequencing, the most commonly used method for mutation detection and delivers test results within an 8 hour period. The test is the third cobas diagnostic test to receive the CE mark approval in the Roche oncology portfolio this year. Other tests include the cobas BRAF Mutation Test for metastatic melanoma and the cobas KRAS Mutation Test for advanced colorectal cancer. The tests run on the cobas 4800 System, v2.0, which standardizes mutation testing across tumor types, and is the only commercial system offering automated result analysis, interpretation and reporting of results.

[1] Murray S. et al. J Thorac Oncol. 2008;3:832-839.
[2] Rosell R et al. J Clin Oncol. 2011;29; Abstract 7503.
[3] Zhou C et al. Lancet Oncol. 2011;12:735?42.

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