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Roche Launches Melanoma Companion Dx in EU After FDA OK Last Week


Roche said this week that European regulators have cleared its Cobas BRAF mutation companion diagnostic for the melanoma drug Zelboraf (vemurafenib).

The European launch comes just a week after the US Food and Drug Administration approved both the assay and drug, which is still under review in the EU.

Roche co-developed Zelboraf with Daiichi Sankyo to treat melanoma patients whose tumors express the BRAF V600E mutation, which is found in about half of all malignant tumors, and which the Cobas BRAF test can detect.

The Cobas BRAF test is a real-time PCR-based assay that runs on Roche's Cobas 4800 system, a consolidated and flexible in vitro diagnostic platform coupled with software that automates result interpretation, analysis, and reporting, the company said.

Roche said in a statement that it clinically validated the test in two studies to identify tumors carrying the BRAF V600E mutation.

It also said the assay has several advantages compared to the commonly used method of Sanger sequencing, such as "greater sensitivity and reliability for detecting mutations and quicker results, allowing doctors to know whether a person with inoperable or metastatic melanoma is eligible for treatment with Zelboraf."

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