YGEN.L Regulatory News (YGEN)

Premaitha Health PLC

Premaitha Health partners with Leeds Teaching Hospitals NHS Trust to offer pregnant women safer non-invasive prenatal screening service

Manchester and Leeds, UK - 2 February 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 has partnered with Leeds Teaching Hospitals NHS Trust to provide a private NIPT screening service for pregnant women in the region.

The IONA® test is a safer and highly accurate way to screen for Down's syndrome (Trisomy 21), Edwards' syndrome (Trisomy 18) and Patau's syndrome (Trisomy 13) to help significantly reduce the need for invasive follow-up tests, such as amniocentesis, which carry a small risk of miscarriage.

A recent recommendation from the National Screening Committee (NSC)1 stated that NIPT should be offered to high risk pregnant women (those with a < 1:150 chance of having a pregnancy affected by Down's syndrome) on the UK's National Health Service (NHS). This has led to an increasing interest in this type of screening from pregnant women. Leeds Teaching Hospitals NHS Trust is the first centre to offer NIPT privately since the recommendation. By providing the test privately at an affordable price within the NHS care pathway all pregnant women, regardless of risk score, have the opportunity to access the benefits of NIPT.

The IONA® test is available to women from 10 weeks' gestation. All the test needs is a blood sample from the mother to estimate the risk of a fetus being affected by Down's syndrome or other serious genetic disorders. The blood sample will be sent to Premaitha's CQC-registered clinical laboratory in Manchester and results provided within three to five working days, minimising anxious waiting time for expectant mothers and their families.

Dr Kelly Cohen, Consultant in Fetomaternal Medicine and Obstetrics at Leeds NHS Teaching Hospitals Trust commented "This is an important step towards increasing the accessibility of non-invasive prenatal screening in Yorkshire. The Fetal Medicine team at LTHT are absolutely committed to ensuring that as many women as possible are able to opt for non-invasive testing until it becomes available as an NHS test. It may not be the best test for everybody, and choosing a screening test can be a confusing and worrying time. We will ensure that our patients are fully informed about their options and will be supported by specialist counselling before and after the test. We've chosen IONA® as we believe it is a highly effective screening test and we look forward to working closely with Premaitha to deliver the best value for our patients."

Dr Stephen Little, CEO of Premaitha Health said: "We look forward to working closely with Leeds Teaching Hospitals NHS Trust to bring this safer test to expectant mothers in Leeds. The IONA® test's proven clinical performance, accuracy and fast turnaround alongside our dedicated CQC-registered clinical laboratory and experience working with the NHS enables us to perfectly support other NHS hospitals to roll out NIPT to women across the UK." 

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1More details on the NSC recommendation can be found here: http://legacy.screening.nhs.uk/fetalanomalies 

About Premaitha Health plc

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 Leeds Teaching Hospitals NHS Trust

The Leeds Teaching Hospitals NHS Trust is one of the largest in England and includes two major teaching hospitals, Leeds General Infirmary and St James's University Hospital. It has a total budget of over £1 billion, employs more than 15,000 staff across sevens main sites, and treats around 1.5 million patients a year.

www.leedsth.nhs.uk