消費者直販型の遺伝学的検査に関する論文がPublic Health Genomics誌に掲載されました

Public Health Genomics誌において、日本における消費者に直接販売される遺伝学的検査と、その規制の現状を報告しました。10月26日付けでオンラインで公開されました。

M. Watanabe, T. Ohata, K. Muto, F. Takada, 2009, Problems in the Regulation of Genetic Tests in Japan: What Can We Learn from Direct-to-Consumer Genetic Tests?, Public Health Genomics, (DOI: 10.1159/000253123).

Abstract

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.