Test of diagnosis that identifies the melanoma tumour mutation already available in Europe
– proof cobas BRAF Mutation is used to identify patients with tumors of melanoma who have a genetic mutation that can be treated with Zelboraf (vemurafenib)
Pleasanton, California, August 23, 2011- / PRNewswire / – Roche (SIX: RO, ROG;) OTCQX: RHHBY) announced today that the cobas BRAF Mutation Test now available commercially in Europe and in countries that recognize the CE mark.
The cobas BRAF Mutation Test is a diagnostic of accompaniment developed by Roche to identify patients with melanoma tumors that carry a mutated form of BRAF gene, and will be suitable for treatment with Zelboraf (vemurafenib), once it is available commercially. The test detects a specific BRAF mutation found in approximately 50 per cent of malignant melanoma tumors. Zelboraf is currently under review in the EU and has just been adopted in United States alongside the test cobas BRAF as new treatment for melanoma metastatic mutation positive BRAF V360.
“Roche has led the way in the development of diagnostic products that enable cancer treatments individual goals”, said Paul Brown, responsible of Roche Molecular Diagnostics (RMD), the business area of Roche who developed the test. “The test cobas BRAF will play a role critical to improve treatment for metastatic melanoma, one of the most aggressive and deadly cancers”.
“Explore patients with this test, which is used to define the population studied in the programme development and melanoma Zelboraf pivotal trials, is the best approach to ensure that appropriate patients have access to this new drug treatment once it is adopted”, said Brown.
Clinical studies on metastatic melanoma demonstrate the cobas test detects mutations in BRAF V360E with a degree of sensitivity, accuracy, reliability and speed higher than other methods of detection not approved and that they are frequently used.
About the cobas 4800 V360 BRAF Mutation Test and cobas 4800 System
The cobas BRAF Mutation Test is a test of diagnostics polymerase chain reaction in real time. The test helps doctors know, on the basis of the tumour BRAF mutation test, if a person with metastatic melanoma is suitable for treatment with the Zelboraf BRAF inhibitor.
The cobas 4800 System is designed to deliver new standards in efficiency of test laboratory and relevant diagnostic information medically. The system is a platform PCR IVD consolidated and flexible designed to deliver high-performance, combined with software that automates the interpretation, analysis and reporting of results.
About metastatic melanoma
When melanoma is detected early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the most dangerous and the form of more aggressive skin cancer. A person with metastatic melanoma usually has a life expectancy short measured in months.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in the health sector focusing on research with forces combined diagnostic and pharmaceutical areas. Roche is the largest biotechnology company in the world with drugs truly differentiated in Oncology, virology, inflammation, metabolism and central nervous system. Roche is also a world leader in in vitro diagnostics, diagnosis of cancer based on tissue, and a pioneer in diabetes treatment. The personalized health strategy Roche aims to provide medicines and diagnostic tools that allow tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in r & d. The Group recorded sales of 49.100 million Swiss francs. Genentech, United States, is a member of full ownership of the Roche Group. Roche has a majority stake
at Chugai Pharmaceutical, Japan.
