The popularity of genomics tests sold directly to consumers has
increased in recent years, with products focusing on ancestry,
health outcomes and genetic traits. Today, the House of Commons
Science and Technology Committee publishes its
Direct-to-consumer genomic testing Report, urging
policymakers to seize opportunities and address
risks posed by the increasing availability and scope of
consumer genomic testing.
Drawing on evidence taken from genomic testing companies,
healthcare professionals and think tanks, the Committee's Report
makes a number of recommendations for the Government to consider
when updating regulations, including:
-
Pre-market assessment of direct-to-consumer
tests by an independent body. This assessment should
cover the test's clinical performance (the
extent to which it can provide information about treatment of a
disease, and the likelihood of improved outcomes) in addition
to the current requirement to achieve analytical
performance, which describes how well the test can
identify the presence of a particular gene.
- The development of technical standards for
direct-to-consumer genomic testing, enabling the
data generated to be used and relied
upon by Genomics England and the NHS. Clearly defining
such standards would facilitate research efforts and reduce the
burden placed on the NHS to re-test patients following testing
via commercially obtained tests. It would also enable
consumers to differentiate high quality, trustworthy products
from those with lower standards.
- Considering whether to revise regulation regarding the
advice and support offered when supplying
genomic testing directly to customers. This could, for example,
include a requirement for provision of genetic
counselling depending on the severity of the condition
being tested, and stipulate the predictive power of the test
alongside results.
- Reconsideration of the guidance on the use of genomic
testing on asymptomatic children. After hearing evidence
from the Nuffield Council of Bioethics and researchers in the
field, the Committee note concerns about testing being used
inappropriately on children who cannot give informed consent.
- The Government should review the adequacy of
the UK’s data protection framework for direct-to-consumer genomic
testing, including the risks and opportunities presented by
technological developments and growing numbers of consumers using
direct-to-consumer genomic tests.
Chair of the Science and Technology Committee, Rt Hon
MP, said:
"For thousands of people, at-home genomic testing has
opened the door to a wealth of new information about our
ancestry, our health and even the likelihood of disease. Done
properly, genomic testing offers great potential for individual
knowledge and can provide data that can advance medical
research.
"However, these technologies can give rise to questions
of quality, which are difficult for consumers to assess, and can
sometimes pose challenging ethical questions. The Government has
committed to a 'gold standard' for ethical and regulatory
standards for genomics in the UK. In our Committee’s Report we
set out perspectives we heard on the issues the Government should
be considering as it devises a new regulatory
framework."
