YGEN.L Regulatory News (YGEN)

Premaitha Health Launches the IONA® test, the First EverCE-marked NIPT Product for Pregnant Women

Manchester, UK - 5 February 2015 - Premaitha Health plc ("Premaitha" or the "Company", AIM: NIPT), an innovative molecular diagnostics company employing the latest advances in DNA analysis technology to develop tests for non-invasive prenatal testing (NIPT) today announces receipt of CE mark approval and launch of the IONA® test, the first CE-marked in vitro diagnostic (IVD) Product for NIPT.

The CE Mark means that the IONA® test has met the stringent quality standards set down by the In Vitro Diagnostic Medical Device Directive (98/79/EC). Premaitha is the only company authorised by the European Regulatory agencies to sell a product to allow a laboratory to offer an NIPT service.

The IONA® test uses next-generation sequencing technology to estimate the risk of a fetus having Down's syndrome (Trisomy 21), Edwards' syndrome (Trisomy 18) and Patau's syndrome (Trisomy 13) by analysing cell-free fetal DNA from a sample of maternal blood. The IONA® test is more sensitive and specific than the current combined test, providing accurate and reliable screening results to pregnant women.

Dr Brenda Kelly, Consultant Obstetrician and Fetal Medicine Specialist at Oxford University Hospitals NHS Trust, said: "The launch of a regulated NIPT test is fantastic news for pregnant women and the clinical team caring for them. At present, a significant number of pregnant women who have a positive screening result with currently available combined and quadruple tests go through unnecessary and stressful follow-up invasive tests such as chorionic villus sampling and amniocentesis, each of which carries a risk of miscarriage. A more accurate and reliable NIPT like IONA® will mean fewer invasive tests and therefore, overall, fewer miscarriages."

Kelly added, "Hospitals across Europe and in the UK now have the option to provide a local test with a rapid turnaround and time to result which will allow 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."

Currently, pregnant women in Europe can only access NIPT via the private testing market provided by service laboratories. This involves sending a blood sample to a lab in the USA or China at considerable cost and with a cumulative waiting time for results of up to two weeks, compared to the IONA® test of only three days.

The IONA® test provides a complete system including DNA extraction through to data analysis with a standardised workflow that can quickly be implemented into clinical laboratories. Having their own solution will result in the acceleration of the broad dissemination of NIPT in Europe, ensuring its benefits are available to many more pregnant women.

Dr Stephen Little, CEO of Premaitha said: "The launch of the IONA® test is a huge milestone for Premaitha. We are the first company to offer a CE-marked NIPT product in an area where the current standard of prenatal testing is simply inadequate and there is a huge unmet need. By moving research technologies into a clinical environment, we are enabling laboratories in Europe to offer this important screening test.

"We have delivered on our promise made on joining AIM in 2014 to launch the IONA® test in early 2015 and we are in a very strong position to take advantage of what is potentially the single biggest opportunity in in vitro diagnostics with a multi-billion dollar potential. NIPT is being welcomed by pregnant women and their doctors, and we expect the uptake to be rapid. I believe that eventually all prenatal screening for trisomies will be based on this approach."

Premaitha is making the IONA® test available to laboratories and hospitals in Europe. The screening test will be rolled out in territories in Asia and the Middle East thereafter. A world-class pan-European commercial team led by Chief Business Officer Peter Collins, previously VP Diagnostics at GSK, is driving the launch. Premaitha's R&D, manufacturing and commercial operation is based at Manchester Science Park, UK.

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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.

Oxford University Hospitals NHS Trust

The Oxford University Hospitals NHS Trust (OUH) is one of the largest acute teaching trusts in the UK, with a national and international reputation for the excellence of its services and its role in patient care, teaching and research. The Trust supports world-leading research programmes in cardiovascular diseases, musculoskeletal disorders, neurological disorders such as Parkinson's and Alzheimer's through its designation as one of the UK's five comprehensive biomedical centres and units. It works in close partnership with the University of Oxford and is a leading centre for cancer, neurosciences, diabetes, genetics and many other fields. 'research themes of particular strength are: cancer, cardiovascular science, diabetes, endocrinology & metabolism, infection and immunology, musculoskeletal science, neuroscience and reproduction and development. The Trust has been designated as a major trauma centre and is one of four UK centres for craniofacial surgery and The Trust employs 11,000 staff and consists of four hospitals: the Churchill Hospital, John Radcliffe Hospital and Nuffield Orthopaedic Centre in Oxford and the Horton General Hospital in Banbury. www.ouh.nhs.uk