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Controls on genetic health tests recommended

14 April 2003
By BioNews
Appeared in BioNews 203

Most genetic tests that offer health information should not be sold directly to the public, the UK's human genetics watchdog recommended last week. In a new report entitled 'Genes direct: ensuring the effective oversight of genetic tests supplied directly to the public', the Human Genetics Commission (HGC) called for stricter controls on predictive genetic tests, but not an outright ban.

The HGC based its report on the findings of a consultation on the sale of so-called 'over the counter' genetic tests, which are becoming increasingly available. Some tests, such as those produced by UK firm Sciona, offer general health advice, but others claim to predict a person's risk of diseases such as cancer. Baroness Helena Kennedy QC, who chairs the commission, said that the majority of genetic tests should be carried out under the supervision of a doctor, and that 'people need to think twice before paying money for something they may not need or understand'.

The report recommends that controls are required to ensure that companies market high quality tests with good customer support, and that kits relying on home testing or sampling should be discouraged. It suggested that a number of bodies could regulate such genetic tests, including the Medicines and Healthcare Products Regulatory Agency (MHRA), the proposed new Human Tissue Authority, and the UK Genetic Testing Network. It also called for a consumer awareness campaign, to help people decide which tests are suitable for them. 'Predictive genetic tests performed without a medical consultation may provide false reassurance or cause unnecessary alarm to people' said Philip Webb, chairman of the group that produced the report.

Call for gene test restrictions
BBC News Online |  9 April 2003
Commission warns against selling genetic tests direct to the public
British Medical Journal |  12 April 2003
Genes direct: Ensuring the effective oversight of genetic tests supplied directly to the public
Human Genetics Commission |  9 April 2003
Genetic test must not go on public sale, Government told
The Times |  10 April 2003
10 December 2007 - by Ailsa Stevens 
A new report - 'More Genes Direct' - published by the UK's Human Genetics Commission (HGC) called for tighter regulation and a review of the European Law which deals with genetic tests. The report - an update of the 2003 version - aims to address growing concerns over the number of...
2 December 2005 - by BioNews 
The US Genetics and Public Policy Center has called for stronger federal oversight of genetic testing in the country. The move stems from concerns over the quality of some of the increasing number of genetic tests available to consumers. The centre, based at Johns Hopkins University, has written to the...
18 March 2005 - by BioNews 
A US company offering genetic tests direct to customers has attracted criticism for not offering patients adequate care, the British Medical Journal (BMJ) reports. But DNA Direct, which offers tests for susceptibility to breast and ovarian cancer via the internet, says it offers customers exactly the same counselling and testing...
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