Foundation Medicine Inc. received approval from the Japanese Ministry of Health, Labour and Welfare for its diagnostic test to detect genetic mutations in any solid tumor type.
Chugai Pharmaceutical Co. Ltd., a member of Roche Holding AG group that holds marketing authorization of FoundationOne CDx in Japan, filed for the approval in March.
FoundationOne CDx can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type and assists in the clinical management of cancer patients. It also identifies which patients may benefit from a range of treatment options.
Foundation Medicine said the Japanese Ministry of Health, Labour and Welfare will issue a reimbursement coverage decision in the first half of 2019, which will determine the payment structure for devices under the country's national health insurance system.
FoundationOne CDx was approved by the U.S. Food and Drug Administration in 2017.
Rouche entered a strategic collaboration with Foundation Medicine in 2015 to advance the progress of personalized treatments for cancer patients.