Premaitha Health has gotten UK’s Department of Health approval to make non-invasive prenatal tests (“NIPT”) routinely available on the NHS to high risk pregnant women across the UK.
The Government’s decision follows a recommendation in January 2016 by the National Screening Committee that NIPT should be made freely available on the NHS, as part of the standard fetal anomaly screening programme, to women with a higher risk of their baby developing Down’s, Edwards’ or Patau’s syndrome, said the company in its announcement issued on Monday.
The company further said that current testing for genetic disorders on the NHS is done through the Combined Test, which is significantly less accurate than NIPT. This results in many women who are incorrectly assessed as being “at risk” for fetal anomalies choosing to undergo an invasive diagnostic procedure, such as amniocentesis, which carries a risk of miscarriage. However, the availability of a safer and highly accurate non-invasive blood test on the NHS, such as Premaitha’s IONA test, is likely to result in a dramatic reduction in the number of women subjected to such invasive procedures.
Premaitha expects NIPT to be rolled out across the NHS to high risk women over the next three years.
Dr Stephen Little, CEO of Premaitha, commented:
“I am delighted that the UK Government is committed to making the process of screening for fetal anomalies a safer one. Through more accurate screening with non-invasive prenatal tests, such as the IONA® test, we will significantly reduce the number of women being referred for follow-up invasive diagnostic procedures.
As the developer of the UK’s leading non-invasive prenatal test, Premaitha looks forward to continuing its work with the NHS to make the IONA test – which is already offered in over 50 NHS institutions – more widely available. We hope that the NHS will seek to adopt only NIPT solutions of the highest certificated quality and that, in time, NIPT will be available to all women on the NHS and not just those perceived to be at the highest risk.”