The regulation of commercial genetic testing services in the UK: a briefing for the Human Genetics Commission
Hogarth, Stuart; Melzer, David; Zimmern, Ron
Cambridge: Department of Public Health and Primary Care, Cambridge University, 2005: 23 p. [Online]. Accessed: http://www.phpc.cam.ac.uk/epg/dtc.pdf [2007 April 17]
"This briefing has been prepared for the Genetic Services sub-group of the Human Genetics Commission (HGC). Its main purpose is to assist members of the Sub-group as they reconvene after a period in which the group has been in abeyance. Its focus is the regulation of commercial genetic testing services, an area the Sub-group is expected to address as it reconvenes. It sets out the history of such activity from the formation of the ACGT [Advisory Committee on Genetic Testing] in 1996 and outlines the complications which arose when this body was absorbed within the newly established HGC in 1999. It briefly outlines the recommendations of Genes Direct, the HGC's report on the regulation of direct-to-public testing and highlights some of the main developments in the period since the report was issued, both in the regulatory arena and in the development of commercial testing services. Annex I analyses the recommendations made in the Genes Direct report pertaining to the IVD [In Vitro Diagnostics] Directive and identifies areas which may be worthy of futher investigation. The briefing also encourages the HGC to clarify its use of the term 'predictive' in the Genes Direct report and Annex 2 seeks to assist in this by listing all the uses of the term in the report." [reprinted from Foreword]
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