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Results obtained from genomic testing must typically be considered in the context of an individual’s...

Recommendation
Results obtained from genomic testing must typically be considered in the context of an individual’s specific circumstance—including their symptoms, personal and family medical history and ethnicity—in order for the clinical significance of those results to be interpreted correctly. These personal details are also often pertinent to the selection of the most appropriate genomic test for an individual. The NHS takes account of these contextual factors through the expert supervision and counselling provided throughout the testing process. In contrast, companies providing genomic testing directly to consumers appear to provide generic tests and depend upon consumers understanding written information provided alongside the test that has not been tailored to their personal situation. The Government should consider the case for amending the regulation of genomic tests provided directly to consumers, to require medical supervision or the provision of genetic counselling for at least some types of genomic testing offered directly to consumers. Criteria used to determine which tests should require medical supervision could include the severity of the conditions being tested for, as well as the predictive power of the test. Requirements for supervision and genetic counselling should cover the qualifications of the medical intermediary required and minimum requirements on the content and format of the support or oversight provided.
Paragraph Reference
64
Government Response
Acknowledged
HM Government Acknowledged
MHRA’s public consultation explores requirements around the information provided to users of DTC genomic tests and the outcome of this will help to inform future policy on how the tests are regulated.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 4.9 yrs
Report published 22 Jun 2021