YGEN.L Regulatory News (YGEN)

Premaitha Health PLC

Premaitha Health welcomes recommendation for NHS provision ofnon-invasive prenatal testing

National Screening Committee recommendation will enable more pregnant women to benefit from NIPT and sets reimbursement precedent for other regions

Manchester, UK - 15 January 2016 - Premaitha Health PLC (AIM: NIPT, "Premaitha" or the "Company"), developer of the IONA® test, the first CE-marked non-invasive prenatal screening (NIPT) product, welcomes the UK National Screening Committee's (NSC) recommendation to routinely offer NIPT testing on the NHS to high risk pregnant women as part of the standard fetal anomaly screening programme.

The recommendation states that the UK National Health Service (NHS) should offer NIPT to high risk pregnant women (those with a 1:150 chance of having a pregnancy affected by Down's syndrome) to significantly reduce invasive testing such as amniocentesis, which carries a small miscarriage risk.

More than one in five pregnant women in the UK are now over 35. As expectant mothers get older there is an increasing chance that their pregnancies will be affected by Down's syndrome with one in 40 pregnancies found to be high risk. This recommendation means that more British women will benefit from having access to NIPT. There are approximately 700,000 live births in the UK every year, this represents a significant and growing market for NIPT.

Dr Stephen Little, CEO of Premaitha Health said: "Today's NSC recommendation is a key milestone for prenatal testing in the UK. This is the first time that NIPT will be routinely available to high risk pregnant women on the NHS and sets a precedent that we expect other countries to follow in the near future. This is an important step towards NIPT becoming available to all pregnant women, not just those at high risk. Premaitha is uniquely positioned to bring the benefits of NIPT to the NHS.

"Our CE-marked IONA® test has already been recognised as providing a superior NIPT product and support service. We partnered with St. George's University Hospitals NHS Foundation Trust last year and together have created the UK's first NIPT Centre of Excellence. As a British company at the heart of the Northern Powerhouse, we are extremely well placed to support the NHS with a rapid roll-out of NIPT across the UK. We look forward to enabling more pregnant women across the country to access NIPT through the NHS and to obtain safer, more accurate and faster results."

Premaitha, directly and in partnership with St. George's University Hospitals NHS Foundation Trust, has been providing NIPT to high-risk women on the NHS using Premaitha's IONA® test (offered as the 'SAFE test' service through St George's) since mid-2015. It also offers women at a lower risk the opportunity to take the test privately and enables other NHS and private clinics across the country to send maternal blood samples for screening. Premaitha anticipates that the endorsement by the NHS will accelerate private payer market growth in the UK.

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More details on the NSC recommendation can be found here: http://legacy.screening.nhs.uk/fetalanomalies

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