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Direct-to-consumer genetic tests: beyond medical regulation?

David Magnus1*, Mildred K Cho1 and Robert Cook-Deegan2

Author Affiliations

1 Stanford Center for Biomedical Ethics, 701A Welch Road, Suite 1105, Palo Alto, CA 94304, USA

2 Center for Genome Ethics, Law & Policy, Institute for Genome Sciences & Policy, Duke University CIEMAS, 101 Science Drive, DUMC Box 3382, Durham, NC 27708, USA

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Genome Med 2009, 1:17  doi:10.1186/gm17

Published: 2 February 2009


The availability of personalized genomic tests, ordered directly by consumers, is rapidly growing. These tests are unlike other genetic or biochemical tests in the sheer amount of data they provide, but interpretation of these genome-wide analyses for health remains uncertain because of the lack of information about environmental and other factors, and because for the vast majority of genetic loci the associations with disease are weak. Although these tests could provide value to customers by offering tools for social networking or genealogy, there are questions about whether and how to regulate these tests and about the extent to which they provide medical information.