FDA resists regulatory role in gene tests
Article Abstract:
The US Food and Drug Administration (FDA) is reluctant to adopt a regulatory role in the conduction of genetic tests offered by specialized laboratories. The refusal is due to the lack of resources to regulate and the possibility of having to regulate several in-house, non-genetic tests. Theoretically, genetic tests fall under FDA regulation but practically FDA has only been involved in diagnostic kits and reagents produced for sale. Genetic screening can reveal susceptibility to disease but the interpretation of the results being uncertain requires regulatory oversight.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 1996
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Hyping results 'could damage' gene therapy
Article Abstract:
The National Institute of Health (NIH) has expressed reservations against the premature optimistic propaganda indulged in by biomedical research groups regarding the potential of the somatic gene therapy. The treatment is still in its preliminary stages and results are not yet authenticated. Under such conditions, patients may develop unwarranted expectations from the therapy if they are made to think that the gene therapy is already effective.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 1995
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Testing time for gene patent as Europe rebels
Article Abstract:
Issues concerning patent rights for gene testing are discussed. In particular the decision of European researchers to ignore the patent filed by Myriad Genetics which covers the diagnostic test for the breast cancer gene BRCA1 is examined.
Publication Name: Nature
Subject: Zoology and wildlife conservation
ISSN: 0028-0836
Year: 2001
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