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US genetic testing advisory committee reports on progress
In an account of the highlights of its fifth meeting, held in public session on 5-7 June 2000, the Secretary's Advisory Committee on Genetic Testing reports on its progress in reviewing public responses to its draft recommendations on the oversight of genetic tests, and in amending its recommendations in the light of these submissions. The Committee decided to clarify the definition of a genetic test, which now includes tests on human DNA, RNA, genes and/or chromosomes, and in addition "the analysis of human proteins and certain metabolites which are predominantly used to detect heritable or acquired genotypes, mutations or phenotypes". The definition excludes other sorts of tests that may contribute to diagnosing a genetic disease but which are not primarily used for that purpose. In other changes to the draft recommendations, the Committee strengthened its recommendations on counselling and informed consent for genetic testing, and clarified the role it proposes for the Federal Drug Administration in the review of new genetic tests. Tests with different "levels of scrutiny" will require different levels of review. The Advisory Committee has also embarked on three new areas of investigation: genetics education and training of health professionals, informed consent of family members in genetics research, and the patenting of genetic tests, hearing expert presentations on these topics.
