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UK Approves Use of NIPT as Part of National Screening Program

NEW YORK (GenomeWeb) – The UK government has approved the use of noninvasive prenatal testing for trisomies 21, 18, and 13 as part of an existing prenatal screening program.

The decision follows a recommendation by the UK National Screening Committee (NSC) in January to evaluate NIPT as a secondary screening test, offering it as an alternative to an invasive diagnostic test for women deemed to be at high risk following the current primary screening test.

"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 noninvasive prenatal test for Down's, Edwards' and Patau's syndromes," said UK Health Minister Philip Dunne in an announcement by the country's Department of Health this week. "By offering noninvasive prenatal testing, fewer pregnant women will go on to be offered diagnostic testing which carries a risk of miscarriage."

Invasive diagnostic tests — using either amniocentesis or chorionic villus sampling — are currently offered to about 10,000 women per year and taken up by about 7,900, according to the department. The hope is that offering NIPT as an alternative could reduce the number of invasive tests to about 1,400 per year, and the number of related miscarriages from 46 to three per year.

"We will closely manage the roll out of noninvasive 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," said Anne Mackie, director of programs for the UK NSC, in the announcement. "We are developing the full detail of the roll out, including the number of sites involved and the results and information to be collected."

NIPT will be rolled out over a three-year period, along with staff training, and the department expects the test to be offered within the UK's National Health Service in 2018 or 2019. The UK NSC will review the evaluation of NIPT on an ongoing basis and may make amendments to the roll out if necessary.

In the meantime, several laboratories have already been providing NIPT within the NHS, including St. George's University Hospitals, which runs a test that is based on Premaitha Health's Iona test, and North East Thames Regional Genetics Laboratory at Great Ormond Street Hospital, which developed its own test. Premaitha said this week that the Iona test is already offered in more than 50 NHS institutions.

In addition, NIPT has been available to women in the UK on a self-pay basis through a number of providers, including TDL Genetics and Health Services Laboratories, which offers Ariosa's Harmony test.