YGEN.L Regulatory News (YGEN)

Premaitha Health plc

("Premaitha" or the "Group")

Legal Settlement and Licence Agreement with Illumina

Manchester, UK - 19 September 2018: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group, is pleased to announce that the Group has entered into a legal settlement and a licence and supply partnership agreement with Illumina Inc. ("Illumina") (the "Agreements"), resolving the current non-invasive prenatal testing ("NIPT") patent infringement litigation.

Key Terms of the Agreements

· Premaitha has taken a licence under Illumina's patent pool for NIPT and is now free to operate in countries where Illumina holds rights to relevant granted patents, including the countries of the European Patent Convention and selected other territories

· Premaitha will develop an IONA® test that runs on Illumina sequencing technology, to be launched in early 2020; and within nine months of signing the Agreements has committed to submitting documentation to a notified body for obtaining CE-IVD certification in Europe for the Illumina-compatible IONA® test

· Premaitha will work with its customers in the licensed territories to migrate to the IONA® test based on Illumina sequencing technology

· Premaitha will make a series of payments in full and final settlement of all ongoing UK litigation. The Directors estimate that these payments will be no more than £1m 

· Once launched, Premaitha will pay Illumina a royalty per sample tested using the IONA® test based on Illumina sequencing technology

Lyn Rees, Chief Executive Officer of Premaitha, commented:

"These Agreements mark the end of a three and a half year intellectual property dispute and the beginning of a new era whereby the Group, working with Illumina, has the ability to provide NIPT to meet rapidly growing global demand.

"Our partnership with Illumina will allow us to move forward and to enter new markets with significant commercial potential. This opens up a much larger addressable market to Premaitha and establishes a new and advanced technological partnership for the IONA® test for NIPT.

"Notwithstanding the challenges of the past several years, these Agreements represent a significant milestone for the Group, expanding our market potential in partnership with Illumina. Premaitha now has the ability to deliver high quality, customer-service-focused clinical genetic tests to a global community."

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 current primary focus is on non-invasive prenatal tests (NIPT) for pregnant women - an emerging, multi-billion dollar global market - although the Group intends to expand its product range into other areas of clinical genetics.

Premaitha's first product, the 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 solution 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.

From May 2018, the Group will trade as Yourgene Health outside of Europe (but remaining as Yourgene Bioscience in Taiwan) reflecting the increased scope of the business in other areas of clinical genetics further to reproductive health; but will maintain the Premaitha Health brand within Europe.

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.