MEPs urge government to review regulation of direct-to-consumer genetic testing
The government must review the ease with which genomic tests can be sold directly to consumers, a Commons committee said, as the popularity of products such as home pedigree kits continues to grow.
The concerns come as Covid-19 has transformed the face of home health care, introducing home testing
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Last September, ministers released the Genome UK report, which sets out a 10-year strategy for Britain to become ‘the world’s most advanced genomic health system’ – including plans for the UK develops new genomic health businesses and increases private sector investment. .
But in their ‘Report on Genomic Tests Directed to Consumers’, released on Tuesday, MEPs on the Science and Technology Committee advised policymakers to address the potential risks posed by the increasing availability and scope of testing. consumer genomics.
This includes products that disclose family ancestry and genetic traits, as well as diagnostic health outcomes.
Drawing on evidence from genomic testing companies, medical professionals and think tanks, the report makes a number of recommendations the government should consider when updating the regulations.
Pre-market evaluation of tests by an independent body
MEPs believe that this assessment should cover the clinical performance of the test – that is, the extent to which it can provide information about the treatment of a disease and the likelihood of improved results – in addition to l ‘current requirement to achieve analytical performance, which describes how well the test can identify the presence of a particular gene.
Development of technical standards
Clearly defining such standards would facilitate research efforts and reduce the burden on the NHS to retest patients after testing via commercially obtained tests, according to the report. It would also allow consumers to differentiate high-quality, trustworthy products from those with lower standards.
Possible update of advice and support offered when providing tests
MEPs said this could, for example, include a requirement to provide genetic counseling based on the severity of the disease being tested, and stipulate the predictive power of the test along with the results.
Review of the use of genomic testing on children
After hearing testimony from the Nuffield Council of Bioethics and researchers in the field, the Committee noted concerns about the inappropriate use of tests on children who cannot give informed consent.
Update the UK’s data protection framework for genomic testing
The government should review the adequacy of the UK data protection framework for direct-to-consumer genomic testing, including the risks and opportunities presented by technological developments and the growing number of consumers using direct-to-consumer genomic testing.
Conservative MP Greg Clark, who chairs the committee, acknowledged in a statement that home genomic testing “has opened the door to a wealth of new information about our ancestry, our health and even the likelihood of illness,” but said that consumers need the right advice. .
“Done correctly, genomic testing offers great potential for individual knowledge and can provide data that can advance medical research,” he said.
“However, these technologies can raise quality questions that are difficult for consumers to assess, and can sometimes pose difficult ethical questions.”
Mr Clark added that the government is committed to providing a “gold standard” for ethical and regulatory standards for genomics in the UK, and noted that the report’s recommendations are the first step in getting there.