The Senate Special Committee on aging, part of The US Government Accountability Office (GAO,) requested a year long investigation on DIY genetic tests as part of the hearing At home DNA tests: Marketing Scam or Medical Breakthrough. The report said the tests are misleading and lack predictive value, and suggests that this advice may exploit the customer.
Dr. Saukko commented: ‘Commercial genetic tests are premature but the issues that arise will come up with genetic tests within the healthcare system as well.’
‘There is very little regulation for clinical tests’, says Prof. Melzer ‘They are not subjected to the rigorous screening that drugs get. The industry regards interpretation of these tests as medical practice, and see their role as just to provide the gizmos (machine, reagents, chips, etc,) that do the tests.
Some exciting progress has been made in this field, for example Prof. Andrew Hattersley recently published work on the genetics of diabetes showing that children with a particular genetic type of diabetes could switch insulin for tablets. But other genetic markers have been shown to be very weak indicators of predispositions. There is an enormous spectrum of tests from the exciting to the useless.’
Dr Saukko agreed: ‘The interesting question is where do we draw the line? This is a grey area particularly in the USA, where the line between commercial testing and healthcare is more blurred. ‘
The test done by the GAO gave different non genetic data for each subject and so the commercial companies disputed the results. They argued that the study was done badly.
Dr Saukko continued ‘The way some government institutions like the GAO and the commercial companies argue about it is rather polarized. Genes have mythical ability to predict health and illness according to commercial sales people, but they are giving lifestyle advice. GAO wants to be the guardian of ‘good’ and ‘appropriate’ science. But how do we define it?’
Egenis and the Peninsular Medical School, funded by the Wellcome Trust are launching a project on this year. ‘We plan to study how exactly controversial and uncertain evidence is presented by different stakeholders.’ explained Dr Saukko.
Prof. Melzer explained the important point was to interpret genetic test results in the context of medical consultations ‘where someone can factor in the particular circumstances of a specific person. Some claims that are being made about genetic tests are driven by non scientific motives.’