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Health Canada approves the cobas® 4800 BRAF V600 Mutation Test, the first Roche companion diagnostic developed with a drug

Roche Diagnostics Canada (SIX: RO, ROG; OTCQX: RHHBY) today announced that Health Canada approved the cobas® 4800 BRAF V600 Mutation Test, a companion diagnostic that identifies patients with metastatic melanoma tumors harboring a mutation in the BRAF gene.

The mutation occurs at a specific location on the BRAF gene – codon 600 – causing it to stay switched on, resulting in unchecked cell proliferation and tumor growth. Approximately 50 percent of melanoma patients carry this mutation. The cobas BRAF test has shown improved sensitivity, accuracy and speed compared to other commonly used detection methods. 

Melanoma patients who have this mutation will be eligible for treatment with the Roche BRAF inhibitor Zelboraf (vemurafenib). Zelboraf, which is designed to selectively target and inhibit mutated BRAF, is already approved in the United States to treat BRAF V600E mutation-positive metastatic melanoma and is currently under review in Canada. Metastatic melanoma is rare, accounting for less than 5% of all skin cancers but causing 90% of all skin cancer related deaths.  The disease is difficult to treat with conventional therapies and until recently, therapies have been limited with no targeted agents available. 

“The approval of the cobas® 4800 BRAF V600 Mutation Test demonstrates Roche’s continued commitment to improving cancer patients’ lives and advancing personalised healthcare”, said Christopher Parker, President and General Manager of Roche Diagnostics in Canada.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.  Roche Canada was founded in 1931. The company employs approximately 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit

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For further information please contact:

Mélanie Lussier
Tel.: 450-686-3137

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