Cobas 4800 BRAF V600 Mutation Test regulatory update

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519, Tokyo, Japan) said Roche submitted an application last month to Japan's Ministry of Health, Labor and Welfare (MHLW) for its cobas 4800 BRAF V600 Mutation Test. The PCR-based nucleic acid test is a companion diagnostic for Zelboraf vemurafenib to identify patients with metastatic melanoma tumors with a mutation in the BRAF gene. The test is approved in the U.S. and Europe. ...