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Australian Government Warns for Caution on DTC Genetic Testing

NEW YORK(GenomeWeb) – Mindful of the advances in genetic technologies and the growing availability of direct-to-consumer genetic tests, the Australian government today published a statement about such tests and guidance for consumers. 

The documents were issued by the National Health and Medical Research Council, which noted that though DTC genetic tests can be a valuable resource to consumers, it also has concerns about the quality of the tests, how they may be used, and a lack of resources about them for consumers. 

"Given phenomenal advances in genetic technologies, more and more companies are offering direct-to-consumer genetic tests," Warwick Anderson, CEO of NHMRC, said in a statement. "These are being taken up by an increasing number of people who are curious about their ancestry or interested in learning about their predisposition to certain health conditions.

"However, consumers should be aware of the implications of using genetic tests which may preclude the advice or involvement of their doctor," he added. "Consumers should be cautious about the accuracy of some of these tests and be mindful that while genetic testing may offer an indication of predisposition to a particular health condition, results should not be treated as a definitive diagnosis." 

NHMRC said that Australian regulators are currently evaluating DTC genetic testing "to ensure that it is included within the national quality and regulatory framework," and noted that the US Food and Drug Administration ordered "a major DTC genetic testing company to cease providing health-related testing until such time that the company can clinically validate its test results," referring to FDA's warning letter to 23andMe late last year to stop providing health reports based on its spit test to consumers, though it could still provide them with uninterpreted genetic information and ancestry reports.

Last week, however, the company launched a pared down version of its Personal Genome Service (PGS) in the UK with CE mark certification.

NHMRC further said that to date, only a "small minority of DTC genetic tests have established their clinical value," and at present most of the tests are research-grade only.

"Because of this lack of agreed evidence base, different DTC genetic testing companies have sometimes been found to return different interpretations of the same DNA sample, due to different analytical or post-analytical approaches." NHMRC said. "Some companies have also been found to provide disease predictions that conflict with established risk for medical conditions."

This article has beend updated from a previous version to clarify the nature of the letter 23andMe received from the FDA last year.