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Pathways, processes and protections: Australia's clinical and direct-to-consumer genetic testing spaces


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Charbonneau, J and Nicol, D ORCID: 0000-0002-6553-2839 2021 , 'Pathways, processes and protections: Australia's clinical and direct-to-consumer genetic testing spaces' , Journal of Law and Medicine, vol. 28, no. 2 , pp. 370-388 .

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Health-related genetic testing, once exclusively within the medical space, is now available within the commercial space. This paradigm shift from medical to consumer presents challenges to regulators, health care professionals and individuals. This section reports on pathways, processes and protections afforded to Australians whether genetic test results are provided by medical professionals or commercial players. While a complex web of protections is available within Australia's medical space, those accessing commercial testing rely on the same protections afforded all consumers in all marketplace transactions. There is also potential for these two initially bifurcated pathways to merge, either by business model or individual choice. Individuals pursuing commercial options obtain personal genetic information, which they self-interpret and, if they choose, share with family, medical professionals and online. While this section focuses on health-related genetic testing, it gives insight into what will undoubtedly be continued incursions into the medical space by commercial players.

Item Type: Article
Authors/Creators:Charbonneau, J and Nicol, D
Keywords: clinical genetic testing, Therapeutic Goods Administration, direct-to-consumer genetic testing, in vitro diagnostic medical devices
Journal or Publication Title: Journal of Law and Medicine
Publisher: Lawbook Co.
ISSN: 1320-159X
Copyright Information:

Copyright 2021 Thomson Reuters Australia

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