16 February 2017 – Publication of scientific paper on Premaitha’s IONA® test

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

Publication of scientific paper on Premaitha’s IONA® test

Manchester, UK – 16 February 2017: Premaitha Health, developer of a leading CE-marked non-invasive prenatal screening system, is pleased to announce the publication of “The IONA® Test: Development of an Automated Cell-Free DNA-Based Screening Test for Fetal Trisomies 13, 18, and 21 That Employs the Ion Proton Semiconductor Sequencing Platform” in Fetal Diagnosis and Therapy.

The paper concludes that the accuracy, robustness and speed of non-invasive prenatal testing (“NIPT”) will result in a positive clinical impact by significantly reducing the number of unnecessary invasive procedures and associated miscarriages, stress, and anxiety of expectant women.

Premaitha’s IONA® test has been developed to provide a simple-to-use, CE-marked, automated workflow comprising instrumentation and analysis software to allow it to be adopted by standard screening laboratories.
The paper outlines how the IONA® test has been established as a robust, automated, CE-IVD test that uses the Ion Proton next generation DNA sequencing platform from ThermoFisher, in a rapid turnaround time of just three days. The software algorithm has been developed, verified and validated on more than 350 samples showing 100% sensitivity and specificity, and a sample failure rate of <0.03%.

Dr William Denman, Chief Medical Officer, of Premaitha Health, commented: “We at Premaitha are seeing the benefits of the IONA® test in practice and are pleased with the accomplishments and achievements of the entire team. The current publication shows the attention to detail, depth of expertise and commitment to improved access and care for pregnant women and their healthcare providers brought to bear on challenging opportunities by Premaitha.”

The article is available with open access:

The IONA ® Test: Development of an Automated Cell-Free DNA-Based Screening Test for Fetal Trisomies 13, 18, and 21 That Employs the Ion Proton Semiconductor Sequencing Platform
Crea, F, Forman, M, Hulme, R, Old, RW, Ryan, D, Mazey, R and Risley, M.

For more information, please contact:

Premaitha Health PLC    
Jo Cross, Head of Marketing    
Tel: +44 (0) 161 667 6865

About Premaitha
Premaitha is a molecular diagnostics company which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved non-invasive screening tests for pregnant women.

Premaitha’s lead test – the IONA® test – was launched in February 2015 and is the leading CE marked complete system which estimates the risk of a fetus being affected with Down’s syndrome or other genetic conditions. The IONA® test is performed on a maternal blood sample – which contains traces of fetal DNA – and then analysed using next generation DNA sequencing technology from ThermoFisher Scientific.

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 stressful and invasive follow up diagnostic procedures which are costly, resource intensive and carry a risk of miscarriage.

Non-invasive prenatal screening is an emerging, multi-billion dollar global market and Premaitha’s complete CE Marked system enables laboratories and health care practitioners to offer an approved, non-invasive prenatal screening system in-house.  

Premaitha is based in Manchester Science Park, United Kingdom and 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.