YGEN.L Regulatory News (YGEN)

Premaitha Health plc

("Premaitha" or the "Company")

Premaitha approved for Good Manufacturing Practice by ANVISA Brazil

Manchester, UK - 29 August 2017: Premaitha Health plc (AIM: NIPT) announces that it has been approved for Brazilian Good Manufacturing Practice ("B-GMP") for the Company's IONA® test by Brazil's regulatory authority, the Agência Nacional de Vigilância Sanitária ("ANVISA").

Premaitha is a leading international molecular diagnostics group focused on non-invasive prenatal testing ("NIPT"). The B-GMP approval enables Premaitha to proceed with the official application to register the IONA® test with ANVISA - Brazil's National Health Surveillance Agency. Premaitha is working closely with Thermo Fisher's local team who will be the Brazilian registration holder and the Company anticipates that registration will take approximately six months. Once registered, the IONA® test will be available to be sold in Brazil as an in-vitro diagnostic product ("IVD").

Premaitha's IONA® test estimates the risk of a fetus being affected with Down's syndrome and other genetic conditions. The test is performed on the 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, commented: "Brazil's IVD registration process has a number of high hurdles to overcome and to have obtained B-GMP approval is a very positive development for the IONA® test. The approval also demonstrates the high quality processes we have embedded at Premaitha, and our effective collaboration with Thermo Fisher.

"We hope to complete full product registration by early 2018 and to launch the IONA® test in Brazil shortly thereafter. Brazil is a very important market in its own right with over three million births per annum and increasing awareness of the benefits and availability of non-invasive prenatal testing. It is also a platform from which to expand into South and Central America, which is another important region in the Company's geographic expansion strategy to drive scale opportunities, and to de-risk our intellectual property exposure." 

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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.