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 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... see more