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The potential for results from non-invasive prenatal testing to influence decisions made on terminating pregnancies...

Conclusion
The potential for results from non-invasive prenatal testing to influence decisions made on terminating pregnancies raises specific issues not encountered by most other genomic tests offered to consumers. Several submissions highlighted the importance of the information and other support provided to those receiving results from such tests to not only ensure comprehension of the result but also to provide balanced, non-directive information about the different options following the test result. Since our predecessor Committee launched its inquiry into direct- to-consumer genomics, there have been several significant developments related to the information and support provided with non-invasive prenatal testing. We hope these will address some of the concerns raised during our inquiry and our predecessor Committee’s inquiry. As the Government considers the requirements that should be introduced on the information provided to consumers using direct-to- consumers genomic tests, it should consider specific requirements for prenatal genomic testing to ensure that the information provided is balanced and non-directive, with accurate information on what might be expected from life for a child or adult with the condition being tested for.
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Government Response
Acknowledged
HM Government Acknowledged
This issue is addressed in MHRA’s consultation, as the information provided alongside such tests is a crucial part of their regulation. There may be a role for the UK National Screening Committee (UKNSC) in providing advice on regulation of prenatal genetic testing, given that they have experience exploring the use of prenatal genetic testing for Down’s Syndrome, Edwards’ Syndrome and Patau’s Syndrome, and appreciate the highly charged and contested debate in the public domain. The wider landscape of prenatal genetic testing is also changing rapidly, for example in recent years there has been a marked increase in the number of private clinics offering non-invasive prenatal testing (NIPT) to expectant mothers. As part of its inspection programme of baby scanning services, the Care Quality Commission (CQC) inspects NIPT services where they are offered in relation to Down’s Syndrome. In such services, CQC expect providers of NIPT to ensure that women using the service fully understand the procedure, understand that it is not a diagnostic test, are informed of the possible outcomes, and have appropriate support available when the test results are delivered. This includes facilitating access to counselling and other relevant services, as well as medical follow-up when needed. The Government will work with the UKNSC and MHRA to establish what actions are required to meet the recommendation, and with the CQC to understand if best practise can be transferred from private clinics to DTC genomic tests.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 4.9 yrs
Report published 22 Jun 2021