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International Standardization

Approaches to International Standardization of Evaluation Methods for Genetic Testing Systems

JBA has accumulated practical and fundamental data in order to propose drafts for the international standards of evaluation methods for genetic testing systems.

Genetic testing and diagnoses have recently spread throughout Japan until they are utilized on a daily basis in clinical settings. In addition, in laboratory testing institutions in this country, the number of laboratory test parameters is increasing rapidly.

This situation has brought about an international consensus on the need for technology development for each genetic test workflow, and for this technology to be reflected in a standardization of the testing systems necessary for genetic tests.

As of the present, however, there exists no established standard, either domestically or internationally, for the total testing system from receipt of the specimen to data processing. Therefore, it is hoped that, by continuing the tests and researches on the system following the previous year and by standardizing the gene expression identification methods and reference standards, Japan expands the genetic testing business and promotes the domestic and international standardization ahead of other countries.

We are actively promoting domestic standardization, while at the same time planning for international standardization of a total genetic testing system that includes the entire workflow from receipt of samples to data processing, which is necessary for performing individual genetic tests such as genetic disease testing and personal identification through DNA examination.

Report Summaries

Domestic Information

  1. Development of the International Standardization
    • Current status of the international standards
      The U.S. and the OECD members are considering to standardize the genetic testing systems, but they have not approached to ISO.
    • About the Approach to International Standardization
      The Japan Bioindustry Association (JBA) has been crafting its strategy for a proposal of international standards in the process of the total international standardization. To achieve its goal of developing research themes, JBA has teamed up with the Japanese Standards Association (JSA) to prepare a proposal for ISO/TC212.
      In order to realize this international standardization proposal, the cooperation of JSA has been gained for standardization as well as researches and development. On the basis of the cooperation, JBA will harmonize with the related governmental organizations and groups, and promote strategic, international activities.
      Research missions are being made overseas, especially to the U.S. and Europe, and global consistency assured while the standardization proposal is being crafted based on the newest information.
  2. JIS draft proposal
    (2000-2001 FY)
    • Determination of lipolytic activity of lipase for industrial use
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    • General rules for preparative liquid chlomatography
  3. Information file

Proposal for ISO/TC212 prepared by JBA

  • Proposal for ISO/TC212 prepared by JBA (to be made public shortly)

ISO-Related Links

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