Rinsho byori. The Japanese journal of clinical pathology
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On July 1st, 2013, about two years after the FDA's drafting of the guidance for companion diagnostics (CoDx), the Ministry of Health, Labour, and Welfare in Japan issued an official notification regarding the co-development of CoDx with a drug which requires dedicated diagnostic tests or medical devices to predict the efficacy of or adverse reactions to the drug. Both recommend to co-develop CoDx and drugs as well as indicate the approved tests and devices on the package insert of the drug. ⋯ This strategically new regulatory framework may allow clinical laboratories certified under the CLIA Act to more easily perform LDT for genetic markers. Unfortunately, no act like the CLIA exits in Japan to promote LDT well validated for clinical practice, and it may be necessary to reform the regulatory classification and requirements and also quality management system for in-vitro diagnostics tests and devices for reimbursement in the future.