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Public Health Genomics. 2010;13(6):327-35. doi: 10.1159/000253123. Epub 2009 Oct 26.

Problems in the regulation of genetic tests in Japan: what can we learn from direct-to-consumer genetic tests?

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Department of Public Policy, Human Genome Center, The Institute of Medical Sciences, University of Tokyo, Tokyo, Japan.


As one of the countries that have invested greatly in the field of bioscience, Japan is facing difficulties introducing human genetic research to the market. A key issue is how to regulate the quality of genetic testing. Since genetic testing is a part of clinical laboratory tests, the regulatory framework for these tests should cover the regulation of genetic testing. Nevertheless, the quality of clinical laboratory tests has been regulated largely by the authority of medical professionals. The fact that genetic testing can be provided without supervision of medical professionals reveals the necessity for the regulation of quality of genetic testing. While medical geneticists have publicly criticized direct-to-consumer (DTC) genetic testing, a group of industries related to DTC genetic testing have established self-regulatory guidelines on the quality control of genetic analysis, based on the OECD guidelines. This article describes the regulatory framework for clinical laboratory tests including genetic tests, and the gaps in regulation, which are particularly highlighted by the appearance of DTC genetic testing. Furthermore the current initiatives taken by different organizations, especially the self-regulatory initiatives by related industries, will be discussed. To conclude the article, recommendations to improve the situation will be made.

[Indexed for MEDLINE]

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