NEW YORK (GenomeWeb) — Foundation Medicine announced today that its FoundationOne CDx genomic profiling assay has received regulatory approval from Japan's Ministry of Health, Labour and Welfare (MHLW).
The next-generation sequencing-based assay — which was approved by the US Food and Drug Administration in late 2017 — is designed to detect substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, as well as select gene rearrangements, known to drive cancer growth. It also detects genomic signatures including microsatellite instability and tumor mutational burden in DNA isolates.
According to Cambridge, Massachusetts-based Foundation Medicine, the MHLW approved FoundationOne CDx as a comprehensive genomic profiling test for all solid tumors and as a companion diagnostic for advanced cancer patients. The agency is expected to issue a reimbursement coverage decision for the assay in the first half of 2019, the company added.
"Similar to our FDA approval in the United States, the MHLW has approved FoundationOne CDx as a comprehensive genomic profiling tool for all solid tumors and a broad companion diagnostic — a first of its kind comprehensive diagnostic test for individuals living with cancer in Japan," Foundation Medicine Chief Business Officer Melanie Nallicheri said in a statement. "This is also an important milestone for our biopharma partners who can leverage FoundationOne CDx to accelerate companion diagnostic development and improve access to personalized oncology care in Japan."
Earlier this year, Foundation Medicine and Chugai Pharmaceutical — both part of Roche — signed an agreement giving Chugai the marketing rights to FoundationOne CDx in Japan.