YGEN.L Regulatory News (YGEN)

Leading London NHS trust teams up with Premaitha Health to create

the UK's first Centre of Excellence for non-invasive prenatal screening

Manchester, UK and London, UK - 23 March 2015 - Premaitha Health plc ("Premaitha", AIM: NIPT) and St George's University Hospitals NHS Foundation Trust ("St George's" or "the Trust") announce today 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 analysing 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 recognised 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.

-Ends-

Notes:

Information about the tender can be found here:

http://www.tendersdirect.co.uk/Search/Tenders/Print.aspx?ID=%20000000004905236

About St George's University Hospitals NHS Foundation Trust

St George's is the regional specialist care provider for South West London, Surrey and beyond. The trust provides a wide range of high quality services, from leading edge hospital care to community health services. With national and regional referrals added to our 3.5m catchment, we serve a population of around 5m people.

The majority of our services are provided from St George's Hospital - a major acute site that is a major trauma centre as well as being a specialist centre for heart attacks and strokes. The work of the trust's emergency department is currently being broadcast to nearly 3m viewers per work on Channel 4's '24 Hours in A&E'.

Around 5,000 babies are delivered each year by the trust's maternity and obstetric service, which ranks among some of the best in the country. The trust has the lowest Caesarean section rate in London, remaining in the low 20s compared to a capital average of 28%. Its reduction in stillbirths has been featured as a leading example on the BBC's Panorama programme - the trust's stillbirth rates are some of the lowest in the UK. The maternity unit has a comparatively high rate of consultant cover, has achieved the best ratings possible in a range of external accreditations and has the highest 'midwife:birth' ratio in London.

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