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Japanese Regulator Approves Foundation Medicine CDx Assay for Roche's Rozlytrek

NEW YORK – Chugai Pharmaceutical, a subsidiary of Roche, announced today that Japan's Ministry of Health, Labour, and Welfare has granted additional approval of Foundation Medicine's FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for entrectinib (Roche's Rozlytrek), marketed in Japan by Chugai.

The drug is for treating neurotrophic tyrosine receptor kinase fusion-positive solid tumors. It is a ROS1/TRK inhibitor and has been approved for treating adult and pediatric patients with NTRK fusion-positive advanced and recurrent solid tumors.

The FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing-based test from Roche's Foundation Medicine, and is used for detecting and analyzing substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures such as microsatellite instability and tumor mutational burden.

The test was previously approved by Japanese regulators in December as a comprehensive genomic profiling test for all solid tumors and as a companion diagnostic for advanced cancer patients.