YGEN.L Regulatory News (YGEN)

Premaitha Health plc

Premaitha completes IONA test validation on Thermo Fisher's Ion S5 instrument

Manchester, UK - 26 May 2017: Premaitha Health plc (AIM: NIPT, "Premaitha" or the "Company"), a leading international molecular diagnostics group focused on prenatal testing, announces that the IONA® test, the Company's CE-IVD non-invasive prenatal test ("NIPT"), has been validated for use on Thermo Fisher Scientific's Ion S5 range of instruments.

The validation of the IONA® test on the Ion S5 platform, performed in partnership with Thermo Fisher Scientific, will broaden Premaitha's potential laboratory customer base. The Ion S5 instrument is now being widely adopted by laboratories carrying out next generation DNA sequencing around the world. The IONA® test is therefore now a possible NIPT solution for this growing network of laboratories. Additionally, as the Ion S5 can be used for wider applications, including oncology, the platform allows Premaitha to work with lower volume laboratories that are keen to offer NIPT as part of a wider choice of genetic tests for their patient populations.

The IONA® test is already validated on Thermo Fisher Scientific's Ion Proton and Ion Chef sequencing instruments (part of the same Ion Torrent platform).

Dr Stephen Little, CEO, commented: "Validation on the Ion S5 is another important technological milestone which achieves a simpler IONA® test workflow, enabling less 'hands-on' time, and provides access to an even greater pool of international laboratory customers that are installing the new platform or who are not solely focused on NIPT. We already have several S5 laboratories ready to roll out the IONA® test, and are in discussions with more."

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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 fetal 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.