A new non-invasive prenatal test (NIPT) for Down’s syndrome, which is deemed safer for women and their babies, has been approved for use in England by the government.
From 2018, women will be offered the safer screening test as an alternative to invasive tests, following a clinical recommendation by experts at the UK National Screening Committee.
“We want women to be able to access the safest screening tests available”
Under the change, clinicians will be trained to offer a simple blood test that is then used to check for DNA fragments of three chromosomal syndromes – Down’s, Edwards’ and Patau’s syndromes.
The additional test could reduce the number of women who choose to have an invasive diagnostic test, which carries a risk of miscarriage, said the Department of Health.
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 – for roughly one in 150 babies – invasive tests either involve taking a sample of amniotic fluid or placental tissue from the womb.
The DH said it was estimated that the new test could result in a fall in the number of women undergoing invasive testing each year – down from 7,900 to 1,400 – and, as a result, reduce the number of miscarriages related to the invasive diagnostic test from around 46 a year to just three.
“We will closely manage the roll out of non-invasive prenatal testing”
The test will be rolled-out gradually over an initial three-year period alongside a programme of staff training. The DH said it expected the test to first be offered in the NHS in 2018-19.
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 Down’s, Edwards’ and Patau’s syndromes.
“By offering non-invasive prenatal testing, fewer pregnant women will go on to be offered diagnostic testing which carries a risk of miscarriage,” he said.
However, some concerns have been raised that the new test, although optional, could spark a rise in terminations of foetuses that test positive for the syndrome.
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,” she said.
“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,” she added.
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In addition, the DH highlighted that the UK National Screening Committee had discussed the findings from a 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 Council’s report, and it has committed to review the evaluation findings as they are generated.
It will allow the committee to decide whether roll-out of the new test should be altered in the light of evidence gathered, said the DH.