Chugai OKd for Genomic Mutation Analysis Cancer Profile Program

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for ‘Foundation One CDx Cancer Genomic Profile,’ a next-generation sequencing based program for the purpose of gene mutation analysis program (for use in cancer genome profiling) for solid tumors and somatic gene mutation analysis program (for use in assessing anticancer drug indications).

This is the first cancer genomic test granted expedited review in May 2018 and approved by the MHLW with the two functions of cancer genomic profiling and companion diagnostics for molecular-targeted drugs.

https://www.marketscreener.com/CHUGAI-PHARMACEUTICAL-CO-6491165/news/Chugai-Pharmaceutical-Obtains-Approval-for-Genomic-Mutation-Analysis-Program-FoundationOne-CDx-Ca-27804995/