Gene tests should be better regulated, says Lords committee

Online genetic tests are “medically irrelevant” and provide “totally useless information,” says a report published by the House of Lords on Monday.

The report highlights concerns about the growing market for tests made available directly to consumers, stating that the United Kingdom had no regulations governing such tests and that consumers were receiving results without adequate medical counselling. Results were likely to be interpreted out of context and could result in further anxiety.

The report recommends that direct to consumer tests should provide comprehensive information regarding the DNA sequences they are testing and the quality of the laboratory being used, so consumers can make informed decisions. This information should show whether the DNA sequence variants used have been validated by genome-wide association studies to predict future risk of disease.

It also recommends that the National Institute for Health and Clinical Excellence implement a programme to evaluate the validity, utility, and costs and benefits of all new genomic tests and that genetic tests should be reclassified to “medium risk,” making them subject to pre-market review before their use.

The House of Lords Science and Technology Committee, which produced the report, made 54 recommendations to the government regarding genomics medicine in the UK.

The inquiry’s chairman, Narendra Patel, told a press conference at the launch that “the use of many types of genomic tests is increasing rapidly both in the NHS and privately.” The report says that most doctors and nurses are inadequately prepared to interpret test results and use them effectively.

It recommends more training in genetics for undergraduate and postgraduate medical students.

The committee also highlighted the need for increased funding to improve IT services in the NHS if genetic testing in multiple gene related disorders such as diabetes was to become a part of normal care. It said that a considerable amount of money was needed to establish such a service.

John Bell, president of the Academy of Medical Sciences, said that genomics would have a major impact on health care but that a “steady hand and clear vision” were needed to deliver clinically useful and cost effective advances.

The committee said that a white paper on genomic medicine was needed to propose long term funding and create a “roadmap for how such developments will be incorporated into the NHS.”