YGEN.L Regulatory News (YGEN)

New contract for IONA® test

Manchester and Leeds, UK - 22 June 2015 - Premaitha Health plc ("Premaitha" or "the Company", AIM: NIPT), developer of the IONA® test, the first CE-marked test for non-invasive prenatal screening (NIPT), announces that it has signed an agreement with This Is My Limited ("This Is My"), a private ultrasound and pregnancy screening clinic group. The partnership aims to provide the IONA® test to pregnant women in the UK at This Is My's clinics in Leeds, Manchester, Liverpool, Hull, Coventry, Halifax, Durham and London.

The IONA® test estimates the risk of a fetus being affected by Down's syndrome and other serious genetic conditions such as Patau's syndrome and Edwards' syndrome by analysing fetal DNA from a sample of maternal blood.

NIPT is more sensitive and specific than the current combined test available on the NHS providing pregnant women and their families with a more accurate and reliable screening result. This reduces the incidence of unnecessary and stressful invasive procedures like amniocentesis, and the associated risk of miscarriage.

The specific advantage of the IONA® test is that pregnant women in the UK can now receive the information they need to make informed decisions in a much shorter timeframe, thereby reducing anxiety. The blood sample can be analysed in local UK laboratories rather than having to be shipped to the US or China. As a result, the waiting time from blood sample to result is only five days, compared to up to two weeks for samples sent abroad.

Dr Stephen Little, CEO of Premaitha said: "NIPT is a substantial improvement to the current standard of pregnancy care. This Is My share our mission to make the IONA® test available to as many pregnant women as possible in the UK and have selected the IONA® test as the preferred NIPT that they offer. This is a strong endorsement of the IONA® test's superior clinical and technical performance and the benefits of being able to provide a result in only five days." 

Judith Pilling, MD of This Is My said: "This agreement establishes This is My as one of the first private companies in the UK to offer Premaitha's ground-breaking IONA® test. We are very pleased to partner with another UK company to deliver what we consider to be the gold-standard in non-invasive prenatal screening to our clients. We look forward to enhancing our pregnancy service with the test, ensuring that expectant mothers can access the information they need about their pregnancy."

-Ends-

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 This Is MyLeeds Ultrasound Screening Service (LUSS) and Genome Ltd (previously Leeds Antenatal Screening Services) joined forces to create The Leeds Screening Centre, which has been providing fetal ultrasound scanning, genetic screening, 4D baby scans and diagnostic ultrasound services since 2003 under the supervision of Mr Gerald Mason, Consultant in Feto-maternal Medicine at Leeds General Infirmary, and Professor Howard Cuckle, Professor of Obstetrics and Gynecology, Columbia University, USA, and Emeritus Professor, School of Medicine, University of Leeds.

The Leeds Screening Centre was acquired in September 2010 by the Optivi Group which refurbished and re-launched the Centre as the first in a planned rollout of this is my: Health Screening & Ultrasound Centres across the UK. New centres have already opened in Hull, Manchester, London Halifax, Liverpool and Coventry, with the new Durham clinic opening in July 2015. Utilising the most hi-tech pioneering techniques, backed up by clinical experts, the clinics offer a comprehensive range of medically supported diagnostic screening, DNA, fertility and pregnancy services.

All centres have large patient waiting areas, fully medically equipped consulting rooms, phlebotomy services and are staffed by specialist medical staff backed by a dedicated support team to ensure a streamlined service is offered 7 days a week with no waiting list.

For further information please visit www.thisismy.co.uk