Premaitha Health plc
(“Premaitha” or the “Company”)
Premaitha’s IONA® test approved for sale in Brazil
Manchester, UK – 5 February 2018: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group focused on prenatal testing, announces that the IONA® test has been approved by Brazil’s regulatory authority, Agência Nacional de Vigilância Sanitária (“ANVISA”), for sale as an in vitro diagnostic (“IVD”) test.
In September 2017, Premaitha announced that the Company’s IONA® test had been approved by ANVISA for Brazilian Good Manufacturing Practice (“B-GMP”). B-GMP approval was required to enable Premaitha to proceed with this official application to register the IONA® test with ANVISA, which was completed ahead of expectations, in under three months.
The Company is now seeking commercial partners in Brazil to bring the benefits of non-invasive prenatal testing to pregnant women and their clinicians in the country.
Premaitha’s IONA® test estimates the risk of a fetus being affected with Down’s syndrome or other genetic conditions. The test is performed on a maternal blood sample, containing traces of fetal DNA, which is then analysed using next generation DNA sequencing technology. The test is highly accurate and significantly reduces the number of women who are unnecessarily subjected to risky, invasive follow up procedures to diagnose Down’s syndrome and other genetic conditions.
Dr Stephen Little, CEO of Premaitha, commented: “Commercialising the IONA® test in this significant South American market is another key step in Premaitha’s diversification and de-risking strategy. Whilst the territory will not be immediately revenue generating, with over three million births per annum, we anticipate Brazil will become a major market for Premaitha and that it will in due course provide a springboard to other South and Central America regions.
“Furthermore, the rapid regulatory approval process is another endorsement of the quality management system Premaitha has built from the outset that is of a calibre suitable for multiple regulatory regimes of the highest standards globally.”
For more information, please contact:
Premaitha Health PLC
Dr Stephen Little, Chief Executive Officer
Barry Hextall, Chief Financial Officer
Joanne Cross, Head of Marketing
Tel: +44 (0)161 667 1053
Cairn Financial Advisers LLP (NOMAD)
Liam Murray / James Caithie
Tel: +44 (0)20 7213 0880
Adrian Hargrave / Scott Mathieson (Corporate Finance)
Andrew Burdis / Abigail Wayne (Corporate Broking)
Tel: +44 (0)20 7220 0500
Ben Simons / Fiona Henson / Antonia Pollock
Tel: +44 (0)20 7830 9700
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.