Direct-to-consumer genetic testing — a regulatory nightmare?

Nicol, Dianne; Hagger, Meredith

doi:10.5694/mja12.10350

Topics

Will the current framework protect consumers effectively?

The age of personalised medicine has seen the rapid emergence of a direct-to-consumer (DTC) genetic testing industry.1 While various forms of DTC testing have been available for many years, the emergence of DTC genetic testing is raising new concerns relating to the accuracy of predictions, and potential harms to consumers given there is typically no individualised genetic counselling.2 DTC testing also has the capacity to increase pressure on an already overstretched health care system if confused consumers seek assistance from health practitioners in interpreting test results.3

University of Tasmania, Hobart, TAS.

Correspondence: Dianne.Nicol@utas.edu.au

Acknowledgements:

We thank Margaret Otlowski, Don Chalmers and John Liddicoat for critical feedback on early drafts of this paper. This research was supported by Australian Research Council Discovery Grant DP11010069.

Competing interests:

Dianne Nicol receives support from the Australian Research Council.

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