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Peer-Reviewed Publication
Ther Innov Regul Sci2018;52(4):482-488.July 1, 2018Journal Article

Direct-to-Consumer Genetic Testing: Finding a Clear Path Forward.

Brendan Seward1
11 Johns Hopkins University, Employee at Clarius Mobile Health Corp, Surrey, British Columbia, Canada.
PubMed DOI

Abstract

Regulatory compliance in the direct-to-consumer genetic testing market is highly sophisticated as there are numerous federal, state, and ethical barriers to entry. In 2010, amid an underregulated market, 23andMe sought to do what few companies in the medical industry had attempted before-disregard the guidance and requests of the US Food and Drug Administration. This regulatory strategy effectivel…

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