• Yoshiaki Tazawa.
• Rinsho Byori. 2014 Apr 1; 62 (4): 381-9.

AbstractOn 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. However, since many useful predictive biomarkers may be discovered after the commercial launch of a drug, the more effective use of laboratory developed tests (LDT) should be considered in order to avoid a biomarker test lag. Due to an increase of clinical needs for multiple biomarker assays using sequence and/or microarray technologies, on November 19th, 2013, the FDA approved 510K clearance for the next-generation sequencer and its universal kit. 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.

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