26 June 2017 – The IONA® test updated to include the first trimester combined test result

Premaitha Health PLC
(“Premaitha” or the “Company”)

The IONA® test updated to include the first trimester combined test result

Manchester, UK – 26 June 2017: Premaitha Health, a leading international molecular diagnostics group focused on non-invasive prenatal testing (“NIPT”), is pleased to announce enhancements to the IONA® test, which now incorporates the first trimester combined test risk score into its software.

The IONA® test is Premaitha’s leading CE-marked non-invasive prenatal test which estimates the risk of a fetus being affected with Down’s syndrome and other fetal trisomies. The optional integration of the first trimester combined test result into the IONA® software, will give a more tailored and specific screening result with IONA® allowing user-preferred prior risk choice. Premaitha believes that the IONA® test is the only NIPT software which integrates the option of using the first trimester combined test result.

The first trimester combined test (“FTCT”) is offered to pregnant women from 11-13 weeks of pregnancy. It combines ultrasound and biochemical results, producing a risk score for chromosomal aneuploidies. Many national screening policies are starting to offer a contingent screening programme, where women have the FTCT and those with a high / intermediate risk result are offered  NIPT. This reduces the number of women that will have to undergo an unnecessary invasive procedure such as amniocentesis, whilst providing the clinical and economic benefit of both screening approaches.

Premaitha has completed a study in conjunction with St George’s NHS Hospital SAFE laboratory on 1,963 samples (398 of which were twins) to validate that the IONA® test, using FTCT, was as accurate as when the prior risk based on maternal age was used. This is being presented as a clinical poster during the 16th World Congress in Fetal Medicine in Ljubljana, Slovenia.

Dr William Denman, Chief Medical Officer of Premaitha Health, commented: “We developed our update to the IONA® test in response to feedback from leading obstetricians and fetal medicine experts worldwide who expressed a desire to have a more comprehensive approach to the management of the prenatal testing. In using the FTCT result we are able to make results more specific and tailor the data for better personalised care and decision making.”

For more information, please contact:

Premaitha Health plc
Joanne Cross, Head of Marketing    
Tel: +44 (0) 161 667 6865
Vigo Communications
Ben Simons / Fiona Henson / Antonia Pollock    
Tel: +44 (0) 20 7830 9700

About Premaitha

Premaitha is an international molecular diagnostics group which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved genetic screening tests. The Group’s primary focus is on non-invasive prenatal tests (NIPT) for pregnant women – an emerging, multi-billion dollar global market.

Premaitha’s IONA® test was launched in 2015 as the first CE-IVD NIPT test in Europe. It enables laboratories and healthcare practitioners to offer a complete CE-marked NIPT system in-house. The IONA® test is performed on a maternal blood sample – which contains traces of placental DNA – and estimates the risk of a fetus being affected with Down’s syndrome or other genetic conditions.

Unlike existing prenatal screening methods, due to its high level of accuracy, the IONA® test can significantly reduce the number of women subjected to unnecessary invasive follow up diagnostic procedures, such as amniocentesis, which are costly, resource intensive and carry a risk of miscarriage.

In March 2017, Premaitha acquired Yourgene Bioscience, a specialist next generation sequencing and bioinformatics company based in Taiwan, with its own NIPT screening test that operates on the same Thermo Fisher next-generation sequencing platform as Premaitha’s IONA® test. Yourgene brings significant benefits to the Group through expanded market access in Asia – the world’s fastest growing NIPT market – as well as opportunities for cross-selling and the ability to jointly develop expanded test content both within NIPT and beyond.

Premaitha is headquartered in Manchester, England, with Yourgene offices in Taipei and Singapore. Its shares trade on the AIM market of the London Stock Exchange (AIM: NIPT). For further information, please visit www.premaitha.com. Follow us on twitter @PremaithaHealth.