YGEN.L Regulatory News (YGEN)

Premaitha Health receives CQC accreditation for new NIPT clinicalservice laboratory to support IONA® test customers

Manchester, UK - 6 July 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), has received Care Quality Commission (CQC) accreditation for its new NIPT service laboratory.

The CQC is an independent regulator of health and social care in England. Its accreditation enables Premaitha to provide the IONA® test as a service in-house to support its customers.

The clinical laboratory service is based on Manchester Science Park, adjacent to Premaitha's headquarters. Its function is to allow new customers to provide pregnant women with access to the IONA® test as soon as possible, whilst their own lab is being established. Premaitha will offer an interim screening facility to which blood samples can be sent.

The service laboratory will also provide an important back-up option for customers during busy periods, ensuring results are delivered to healthcare professionals on-time and from a regulated and trusted clinical laboratory.

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. The test is more sensitive and specific than the current combined test available and provides a more accurate and reliable screening result.

Dr Stephen Little, CEO of Premaitha said: "We want to be able to offer a clinical laboratory service to support customers keen to provide the IONA® test at the earliest possible opportunity. The accreditation validates the quality of our facilities and the expertise of our clinical scientists. Together, with our partners, we can bring the benefits of NIPT to more pregnant women, sooner."

As a CE-marked in vitro diagnostic product, the IONA® test enables clinical laboratories across Europe to offer their own decentralised NIPT service in-house, analysing blood samples locally rather than having to ship them to labs in the US or China. This provides a much shorter time to result, dramatically reducing the stressful waiting time for pregnant women and their families.

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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 non-NIPT 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.