Cobas 4800 BRAF V600 Mutation Test regulatory update

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519, Tokyo, Japan) said Japan approved Roche’s cobas 4800 BRAF V600 Mutation Test as a companion diagnostic for Zelboraf vemurafenib to identify patients with metastatic melanoma tumors with a mutation in the BRAF gene. The PCR-based nucleic acid test is approved in the EU and U.S. Japan recently approved Zelboraf -- an oral small molecule inhibitor of the oncogenic BRAF V600E -- to treat unresectable melanoma with a BRAF V600 mutation. ...