YGEN.L Regulatory News (YGEN)

Premaitha Health PLC

("Premaitha" or the "Company")

Premaitha launches Sage™ prenatal screening solution in Hong Kong

Manchester, UK - 16 June 2017: Premaitha Health PLC (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing ("NIPT"), announces the launch of Sage™, an NIPT solution incorporating additional prenatal screening analysis tools.

Sage™ is an advanced NIPT analysis solution, available through Yourgene Bioscience Singapore ("Yourgene"), which was acquired by Premaitha in March 2017. It uses the latest technology to detect placental DNA in a maternal blood sample, enabling pregnant women to get fast, safe and reliable test results whilst reducing the number of women required to undergo invasive follow up tests with the associated risks.

Sage™ offers customers a cost-effective, high-quality and flexible prenatal screening test that can be tailored to provide a full clinical service for hospitals or to local laboratory set-ups, all with a fast workflow of just three days. Utilising cloud-based bioinformatics analysis, Sage™ allows laboratories to upload sequencing data files to the cloud for remote analysis via Yourgene's bespoke portal analysis package.

This solution will significantly expand Premaitha's addressable market, giving access not only to new customers, but also offering additional analysis tools for existing IONA® customers. Sage™ is a complementary solution to IONA® as Premaitha's CE-marked IONA® test detects trisomies 21, 18 and 13, whereas Sage™ offers an extended test panel, including full chromosome analysis, thereby enabling customers to maintain a competitive edge in the growing number of laboratories offering NIPT.

Health authorities implementing public health screening policies often mandate the use of a CE-marked test, such as IONA® test, or equivalent. The launch of Sage™ will enable Premaitha to capitalise on the growing awareness and demand for NIPT in countries that have not yet seen the implementation of standard regulation and for the private payer market in cases where public provision is not available.

The Sage™ analysis solution has been developed utilising the sequencing and bioinformatics expertise of Yourgene, alongside Premaitha's clinical understanding, IVD and quality standards. Sage™ is being launched at the Asian and Oceanic Obstetric Congress of Obstetrics and Gynaecology in Hong Kong, where the Company will be exhibiting and showcasing both the Sage™ solution and the IONA® test.

Dr Stephen Little, CEO of Premaitha Health, commented: "To be able to launch the Sage™ test, a valuable addition to the Premaitha portfolio, having only completed the acquisition of Yourgene three months ago, is a real testament to the capabilities and expertise across our technical, clinical and commercial teams.

"The launch of Sage™ presents a significant opportunity to extend Premaitha's footprint and market penetration across Asia Pacific and other regions. Yourgene already has a strong, established network of customers across APAC and we are now in a position to offer a complete NIPT solution to address the needs of any laboratory, with our IONA® test continuing to service demand for premium CE-IVD testing.

"Our team will work with local customers across the APAC region to increase understanding of the benefits of NIPT and raise awareness in and amongst clinicians. Premaitha is also very keen to support healthcare professionals offering Sage™ and IONA® with comprehensive clinical and technical training to ensure they are well equipped to counsel pregnant women on their NIPT options."

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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 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.