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Med Sci (Paris). 2020 Feb;36(2):153-159. doi: 10.1051/medsci/2019264. Epub 2020 Mar 4.

[Direct-to-consumer genetic testing: a regulation by the market, or a medical regulation?]

[Article in French; Abstract available in French from the publisher]

Author information

1
LISST-Cers (UMR 5193), Université Toulouse II, UFR Sciences Espaces et Sociétés, Département de Sociologie, 31058 Toulouse Cedex 9, France.

Abstract

in English, French

The direct-to-consumer genetic testing (DTC-GT) market has been developing for about twenty years now, raising various debates, even controversies. But what about the regulation of these so-called "innovative" devices, but whose medical status is ambiguous? A first regulatory aspect is depending on the market itself, since the latter is currently subjected to a strong structuring process. A second regulatory aspect, more classical, is the legal one. While the DTC-GT status has long been unclear on European scale, a new text (a Regulation, not a Directive) is modifying the situation. It encourages regulation "by the market" rather than "by the medical profession", which does not imply that the latter will have no (indirect) impact on the DTC-GT market.

PMID:
32129752
DOI:
10.1051/medsci/2019264

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