YGEN.L Regulatory News (YGEN)

Independent performance study of the IONA® test published

Further verification of the test showing 100% of trisomies detected and 0% false positives from 242 maternal blood samples

Manchester, UK - 12 October 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), announces the results of a study on the first-trimester detection of trisomy 21, 18 and 13 using the IONA® test1. The study was undertaken by a team led by Professor Kypros Nicolaides with Dr Liona Poon as the lead author at the Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, and was published in the Journal of Ultrasound in Obstetrics and Gynaecology.

The blinded validation study, assessed the potential performance of the IONA® test in using cell-free DNA analysis of 242 maternal blood samples to screen for Down's syndrome (Trisomy 21), Edwards' syndrome (Trisomy 18) and Patau's syndrome (Trisomy 13). Samples were obtained from pregnant women at 11 to 13 weeks gestation before choroinic villus sampling. The maternal plasma samples were then analysed in Premaitha's laboratories using the IONA® test.

The test results were analysed using the IONA® Software, Premaitha's bespoke bioinformatics package available for all clinical laboratory customers. The IONA® test measures the relative amount of chromosomes 21, 18 and 13 in the maternal plasma sample to calculate a likelihood ratio to predict the presence of a trisomy. This data is coupled with the background risk associated with maternal age to determine an adjusted probability of the fetus having a trisomy of chromosome 21, 18 or 13. Of the 242 samples; 35 were trisomy 21, 4 were trisomy 18, and 2 were trisomy 13. The IONA® test detected 100% of all trisomies with a false positive rate of 0%.

Prof Kypros Nicolaides commented on the study "I am very impressed by the accuracy of the IONA® test" and Dr Liona Poon, both at the Harris Birthright Research Centre for Fetal Medicine, Division of Women's Health, King's College London said: "I hope the new technology used in the IONA® test will allow easy implementation of cfDNA testing in the screening for major fetal aneuploidies."

Dr William Denman, Chief Medical Officer at Premaitha said: "These results confirm what our customers have already reported; that the IONA® test is a highly accurate, robust and simple screen for Down's syndrome and other serious genetic conditions. It is a great endorsement of the test that Professor Nicolaides and his team have chosen to verify it. We believe this should encourage broader and appropriate uptake of NIPT, benefiting pregnant women and their families through the increased accuracy, especially the reduction in false positive results that the IONA® test provides."

NIPT is more sensitive and specific than the currently available combined test. NIPT provides pregnant women and their families a more accurate and reliable screening result, reducing the incidence of unnecessary and stressful invasive procedures like amniocentesis, and the associated risk of miscarriage.

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Premaitha are exhibiting at the 25th World Congress on Ultrasound in Obstetrics and Gynecology, please visit us at booth 102.

1Ultrasound Obstet Gynecol. 2015 Sep 21. doi: 10.1002/uog.15749. The IONA® test for first-trimester detection of trisomy 21, 18 and 13. Poon LC1, Dumidrascu-Diris D1, Francisco C1, Fantasia I1, Nicolaides KH1.

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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

About Harris Birthright Research Centre for Fetal Medicine

The Harris Birthright Research Centre for Fetal Medicine was set up in 1984 through the generosity of Sir Philip Harris and the charity organisation Birthright. It has developed into a major research and clinical unit for fetal diagnosis and therapy. Each year more than 10,000 patients benefit from its services and up to 100 doctors, midwives and scientists visit to observe its clinical activities and to participate in research. More than 400 papers have been published in scientific journals.

For further information please visit www.harrisbirthright.org