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As well as companies offering products to consumers that combine genomic testing with analysis of...
Recommendation
As well as companies offering products to consumers that combine genomic testing with analysis of the genomic data obtained through the test, some companies offer secondary analysis of genomic data obtained through a previous genomic test from a different company. There is a potentially increased risk that the testing process used to obtain the genomic data is unsuitable for the analysis performed by a company offering secondary analysis. Despite this, the current regulation may not apply to companies providing secondary analysis of genomic data if their product is not deemed to include the use of physical equipment. The Government should consider extending the definition of products covered by the regulation of genomic tests to include software and other services offering analysis and interpretation of genomic test results obtained from third parties. (Paragraph 104) Direct-to-consumer genomic testing 55
Government Response
Acknowledged
Government Response
Acknowledged
HM Government
Acknowledged
MHRA’s public consultation explores the scope of medical device regulations in the UK and the outcome of this will help to inform future policy on this recommendation.
Source
Inquiry
Commercial genomics
Report
First Report - Direct-to-consumer genomic testing
22 Jun 2021
HC 94
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age
4.9 yrs
Report published
22 Jun 2021