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Australian experts criticise unregulated direct-to-consumer genetic testing industry

12 August 2008
Appeared in BioNews 470

Government officials in Australia have held a joint public meeting to discuss the dangers of the burgeoning but largely unregulated direct-to-consumer genetic testing market. Chair Professor Ron Trent from the National Health and Medical Research Council, Human Genetics Advisory Committee (HGAC) and Professor David Weisbrot, the president of the Australian Law Reform Commission, warned that the predictive genomic testing industry lacks a regulatory entity to ensure the medical validity or accuracy of available tests and lacks standards to help consumers understand test results.

It is estimated that 1,400 such tests are currently available, predominantly online, by genomic companies mainly based in the US and Europe - over 30 US compared with only six Australian companies test for serious diseases like cancer. HGAC Chair Professor Ron Trent worries that online testing based abroad particularly denies Australian residents proper recourse or access to advice which he stresses should accompany results: 'Sometimes counselling requires one or two visits, sometimes it requires family members to come in and get involved.'

Trent also warns that interpreting the significance of genetic test results can be complex due multiple inter-related genetic and environmental causes, so that allowing individuals to bypass physicians and obtain their personal DNA results could 'do more harm than good'. He criticises claims that identifying diabetes-linked genetic markers means they can predict if you're going to develop diabetes. 'I think that's taking it a little bit too far', he said. 'We want consumer authorities to be looking very carefully at the claims that are being made for some of these tests. Some are patently ludicrous, some are a little bit exaggerated,' said Weisbrot. Both fear that without better regulation and medical supervision, bogus testing may give legitimate genetic testing a bad reputation.

The majority of online tests offer 'lifestyle' non-medical DNA information - such as about balding or wrinkles - but experts fear that the distinction is unclear. The ability of many of these tests to reliably predict risk of disease and scan for traits like lactose-intolerance is largely unknown. Experts fear that predictive genomic test results, particularly for serious diseases, may cause needless worry or give false reassurance. However, Ryan Phelan, CEO of DNA Direct, which screens for breast cancer, criticises any blanket policy approach. He suggests 'nuanced regulation' that distinguishes between tests predicting serious disease from non-medical or interesting information is required.

The meeting coincides with the release of results from the first national audit of consumer genomics. A total of 160,000 tests - for more than 400 medical conditions - were performed in 2006. The study, funded by Australia's federal Department of Health and Ageing, was led by Dr Graeme Suthers, who said 'we're in transition from a cottage industry to the inclusion of genetic testing in mainstream medicine.' The study found that around 40 per cent of the tests involved screening healthy people for genes that could cause diseases such as cystic fibrosis in their children or screening for tissue compatibility; 28 per cent performed diagnostic testing to seek or eliminate genetic factors, and eight per cent were conducted on cancer cells to check for genetic damage. Tests for inherited cancer-causing mutations on family members comprised five per cent. Suthers also found that genetic testing to reveal cancer drug-treatment efficacy is increasing and successful. The varied uses and high-volume of certain testing suggests that genetic testing has an important and increasing role in healthcare and many argue that all genetic testing should be regulated through healthcare providers.

Previously most governments have concentrated on preventing employers and insurers from misusing the genetic information such tests yield. Recently, leading nations have switched focus: both the UK and US have issued warnings and initiated government consultations for reform whilst California and New York aggressively cracked down on companies based there. Australia now joins these efforts and already allows genetic testing for medical conditions only by physician-referral to licensed laboratories. However, the direct-to-consumer market circumvents requirements for physician involvement because such tests generally classify as 'low-risk' under existing consumer laws.

Their online availability raises concerns of how the international service aspect can effectively be regulated by federal/state regulations if companies are able to out-source DNA-analysis to nations that lack oversight laws. Genomic companies welcome good-practice standards but object to physician involvement preventing a direct-to-consumer market. They contend that DNA-analysis is not medical testing but personal genetic 'informational services' and should be regulated like over-the-counter tests.

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