Premaitha Health plc highlights new clinical data on the IONA® test that was presented by leading fetal medicine consultants at the World Congress in Fetal Medicine, Crete on Monday 22 June 2015.
IONA® is an advanced screening test that analyses cell-free fetal DNA from a sample of maternal blood to estimate the risk of serious chromosomal disorders such as Down’s syndrome (Trisomy 21), Edwards’ syndrome (Trisomy 18) and Patau’s syndrome (Trisomy 13). As a CE-marked product the IONA® test enables clinical laboratories to offer an NIPT service run in-house.
Dr Brenda Kelly, Consultant Obstetrician and Fetal Medicine Specialist at Oxford University Hospitals NHS Trust, UK presented clinical validation data of the IONA® test. The results were 100% accurate with no false positives. The data was based on the analysis of 442 patient samples from six clinical sites in the UK. Trisomy 21 was detected in 43 samples, Trisomy 18 in 10 samples and Trisomy 13 in five samples.
Dr Kelly stated: “The IONA® test really opens the way for wider implementation of cell free DNA screening, allowing regional laboratories to provide this valuable service.”
Dr Liona Poon, Clinical Senior Lecturer and Consultant in Fetal Medicine and Obstetrics at Harris Birthright Research Centre for Fetal Medicine, Division of Women's Health, King's College London, UK also presented data on the screening performance of the IONA® test in pregnant women 11-13 weeks, showing the same results in earlier gestational ages.
Dr William Denman, Chief Medical Officer at Premaitha said: “To have such influential fetal medicine consultants lead clinical studies for the IONA® test is a great endorsement of its capabilities. We are delighted with the results and the opportunity to present at this prestigious international conference.”