Premaitha Health plc and St George’s University Hospitals NHS Foundation Trust have announced that Premaitha has been awarded the contract to provide its non-invasive prenatal test (NIPT), the IONA® test, to St George’s following a competitive tender process.
The Trust, based at St George’s Hospital in South West London, will be the first NHS facility to offer an in-house NIPT screening for pregnant women in the UK. The project award is a three-year contract with options to extend annually.
Non-invasive prenatal test (NIPT) is an advanced screening test for pregnant women, using a small blood sample rather than an invasive procedure such as an amniocentisis, the test estimates the risk of a fetus having Down’s syndrome or other serious genetic diseases.
Until now, pregnant women in the UK could only access NIPT privately, with blood samples being sent to the US or China. Not only was this costly but carried a waiting time of up to two weeks which is a long time when parents may need to make decisions about their pregnancies.
The IONA® test is the first CE-marked in vitro diagnostic (IVD) product for NIPT. It uses next-generation sequencing (NGS) technology to estimate the risk of a fetus having serious genetic disorders such as Down syndrome (Trisomy 21), Edward syndrome (Trisomy 18) and Patau syndrome (Trisomy 13) by analyzing cell-free fetal DNA from a sample of maternal blood.
Working in partnership, Premaitha and the Trust intend to establish St George’s NIPT service as a UK Centre of Excellence for Prenatal Screening enabling the Trust to offer this test to pregnant women through the NHS and also privately. This will provide accurate and reliable results in a matter of days, allowing pregnant women and their families to receive the information they need to make informed decisions in a much faster timeframe, reducing anxiety as much as possible.
Professor Basky Thilaganathan, Consultant Obstetrician at St George’s commented, “This is great news for the trust and for pregnant women in the UK. NIPT has the potential to make a huge difference to the care and reassurance that clinicians can offer to pregnant women. Too many have been through the anxiety and discomfort of invasive procedures after receiving false positive results from the combined test - the IONA® test gives us the accuracy and reliability to reduce this number significantly. We are very happy to be able to partner with a UK innovator like Premaitha to create an UK Centre of Excellence using the first regulated NIPT test.”
Dr Stephen Little, CEO of Premaitha added: “This award by St George’s is a strong endorsement of the robustness, reliability and accuracy of the IONA® test and we are pleased to be able to collaborate with the Trust to make the many benefits of NIPT a reality for pregnant women and clinicians within the UK. We recognized the limitations in the current standard of prenatal screening and the huge unmet medical need for a regulated test that centres such as St George’s could provide in-house. We are working closely with the St George’s team to get the IONA® test up and running as soon as possible.”
NIPT has a higher detection rate and lower false positive rate than the current combined test offered to pregnant women in the UK. The greatly reduced false positive rate of the IONA® test also means that fewer pregnant women will undergo unnecessary invasive follow-up procedures such as amniocentesis and chronic villus sampling which are stressful and carry a small risk of miscarriage.