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

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

In Australia, a number of companies advertise genetic testing directly to consumers. While some require that a health professional orders the tests and communicates results to the consumer, others offer unmediated services. Internationally, private companies are entering the DTC genetic testing market in increasing numbers. More likely than not, Australian consumers are responding to online advertising by these companies and sending their tissue samples for analysis overseas.

There is a…