24 Jun 2015 07:00
New IONA® test clinical data showcased at theWorld Congress in Fetal Medicine
Manchester, UK - 24 June 2015 - Premaitha Health plc ("Premaitha" or "the Company", AIM: NIPT), developer of the IONA® test, the first CE-marked non-invasive prenatal screening test (NIPT), 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."
-Ends-
For more information, please contact:
Premaitha Health plcDr Stephen Little, Chief Executive Officer Jo Cross, Head of Marketing | Tel: +44 (0) 161 667 6865Email: investors@premaitha.com joanne.cross@premaitha.com
|
Instinctif PartnersJen Lewis / Emma Barlow | Tel: +44 (0) 207 457 2020 Email: premaitha@instinctif.com |
About Premaitha Health
Premaitha is an innovative molecular diagnostics company employing the latest advances in DNA analysis technology to develop tests for non-invasive prenatal screening (NIPT) and other applications. Premaitha's flagship product, the IONA® test is the first non-invasive in vitro diagnostic product for prenatal screening enabling clinical laboratories to offer CE-marked NIPT in-house for the first time.
The IONA® test estimates the risk of a fetus having Down's syndrome or other serious genetic diseases. The IONA® test has a higher detection rate and lower false positive rate than existing screening tests, giving pregnant women, their families and their doctors greater confidence in the result and reducing the need for unnecessary invasive follow-up tests and the associated anxiety and stress.
The IONA® test is a complete diagnostic system that is simple and standardised, enabling Premaitha's clinical laboratory customers to perform the test in their own facilities. This supports Premaitha's strategy of accelerating the broad dissemination of NIPT tests to ensure that their benefits are available to pregnant women everywhere.
Premaitha is listed on the London Stock Exchange (AIM). Its R&D, manufacturing and commercial operation is located at Manchester Science Park, UK.
For further information please visit www.premaitha.com or email iona@premaitha.com