Department of Health
Following a clinical recommendation by experts at the UK National Screening Committee, a new non-invasive prenatal test for Downs, Edwards and Pataus syndromes, which is safer for women and their babies, has been approved.
This additional test could reduce the number of women who choose to have an invasive diagnostic test which carries a risk of miscarriage.
From 2018, women will be offered a safer screening test as an alternative to the invasive tests. A simple blood test will be offered which is then used to check for DNA fragments of these chromosomal syndromes.
Health Minister Philip Dunne said:
We want women to be able to access the safest screening tests available, so based on the clinical evidence, we have approved the use of a new non-invasive prenatal test for Downs, Edwards and Pataus syndromes. By offering non-invasive prenatal testing, fewer pregnant women will go on to be offered diagnostic testing which carries a risk of miscarriage.
Invasive tests are currently offered to around 10,000 women a year and when a blood test and ultrasound show a higher chance of their baby developing the syndromes. Where the chance is higher which is the case for roughly 1 in 150 babies invasive tests either involve taking a sample of amniotic fluid or placental tissue from the womb. The procedure carries a small risk of miscarriage due to the removal of a small sample of cells from amniotic fluid around the foetus.
The new test could result in a fall in the number of women undergoing invasive testing each year (an estimated reduction from 7,900 to 1,400). This could reduce the number of miscarriages related to the invasive diagnostic test from 46 to approximately 3 per year.
All pregnant women and their families are provided with support and information to help them make informed choices about their pregnancies.
The test will be rolled-out gradually over an initial 3-year period alongside a programme of staff training. We expect the test to first be offered in the NHS in 2018/2019.
Dr Anne Mackie, Director of Programmes for the UK National Screening Committee said:
We will closely manage the roll out of non-invasive prenatal testing to give us a better understanding of the impact it has on the decisions women and their partners make following their test results. We are developing the full detail of the roll out, including the number of sites involved and the results and information to be collected. Key to ensuring we get this right is the work we are doing with patient groups, scientists and clinicians, to help us develop balanced informative resources for the public and health professionals.
In addition, the UK National Screening Committee discussed the findings from the workshop held by the Nuffield Council on Bioethics in January. Alongside the fact that foetal anomaly screening is well established in the UK, the committee considered that the use of a more accurate test brings no new ethical issues about screening.
However, the committee did note the issues raised, in both responses to its own review and Nuffield Councils report, and it has committed to review the evaluation findings as they are generated. This will allow the committee to decide whether roll-out of the new test should be altered in the light of evidence gathered.