2000 Standardization of evaluation methods for genetic testing systems : International Standardization : Japan Bioindustry Association

2000 Standardization of evaluation methods for genetic testing systems (The international standards development projects for support of the new industry) Report Summary

The development of technology essential to the operations involved in genetic testing and the establishment of standards for the systems necessary for such testing are highly desirable developments on an international scale. Specifically, with the expanding role of biotechnology in society, including its use in testing for genetic diseases and the identification of individuals through DNA assessment, this standardization must encompass the total testing system, from sample preparation to data processing. Such system standardization will enable standardize and implement highly accurate genetic testing, and it is anticipated that the market for genetic testing will grow sharply as a result.
Elements such as certification of test data reliability and the competence of workers performing the tests are being implemented by private organizations in countries such as the U.S. and France. However, no standards have been established in Japan or internationally with regard to a total system comprising all stages from sample preparation to data processing. Therefore, by continuing the testing and study of this total system that was begun last year and working to bring conformity to areas such as gene expression studies and reference standards, Japan must take the initiative in moving toward domestic and international standardization.

Examine study results and prepare domestic and overseas surveys

a) In addition to domestic and overseas surveys, international exchanges with the U.S. FDA, CAP and similar organizations will be planned, and efforts will be made to ensure consistency based on accuracy control standards for genetic testing systems. Plans will also be made to coordinate standards in response to international standardization, with a view to strategic international activities.

b) Based on the results of studies of genetic testing systems performed last year and this year, the fact-finding committee will conduct investigations and formulate conclusions with the aim of international standardization.

Standardize sample processing and testing techniques (e.g., PCR, FISH, Southern blotting, and DNA microarray)

a) Standardization of genetic testing systems
Items that require standardization from the ongoing studies begun last year will be investigated, including sample receipt, testing, data analysis, and report formats.

b) Examination of gene expression testing
Testing sensitivity and methods of designing probes and primers will be investigated to construct various types of genetic testing systems.

c) Verification of enzyme reagents and assay equipment used in genetic testing
The units and stability of heat-resistant enzymes and primer reagents will be verified and equipment (e.g., electrophoresis devices) validated.

Standardize reference standards used in genetic testing

a) Cross-checking between institutions (subcontractors) will be carried out for the same test parameters.

Reference standards will be prepared and thereby carrying out cross-checking between institutions in order to establish the objectively graspable system. b) Preparation and standardization of positive controls
Reference standards will be prepared and efforts made to ensure standardization between institutions.
Prepare main points of international specifications and draft plan for international standardization activities
The status of genetic testing systems in Japan and other countries will be surveyed and international specifications prepared with the aim of international standardization. Specifically, international exchanges with organizations such as the American Society of Clinical Pathologists will be planned and, based on the accuracy control standards of the society, efforts will be made to standardize the evaluation procedures used to control the testing process for applicable genetic tests in Japan. In addition, a plan will be drafted for international standardization activities related to genetic testing systems.

Progress toward international standards

(1) Current status international specifications
International exchanges will be planned with the FDA and CAP in the U.S. and, based on accuracy control standards for genetic testing systems, efforts will be made to achieve coordination and expand strategic international activities. Because there is no TC for the biological fields in the ISO, the U.S. and OECD have already begun to examine the standardization of genetic testing systems. Therefore, the comprehensive fact-finding committee must urgently examine this area and plan the implementation of international standards.

(2) Approaches to international standardization

After careful consideration of a strategy for proposing an international specification, preparations will be made for an ISO/TC212 proposal in cooperation with the Japanese Standards Association (JSA) in order to achieve the objective of developing the research topic. In addition, as a concurrent part of the research and development, strategic international activities will be expanded in order to propose international standards. The aim of these activities, which will also be undertaken with the cooperation of the JSA, will be to ensure consistency with relevant governmental institutions and organizations concerned with international standardization. In particular, efforts will be made to ensure consistency with other countries by conducting on-site surveys in the U.S. and Europe and preparing standards proposals based on current information.
Given the urgency of the current situation in Japan, English translations will be undertaken immediately with the aim of international standardization. As soon as possible after the completion of the research and development, the domestic subcontractors and results will be gathered, and the results will be disclosed through their practical application domestically together with efforts to facilitate standardization.