17th Feb 2020 12:49
(Alliance News) - Yourgene Health PLC on Monday said it has submitted the CE Marking Technical File for its IONA prenatal test as it seeks a European CE Marking Certificate.
Shares in molecular diagnostics firm Yourgene were up 2.6% at 15.39 pence at midday in London.
The CE Marking Technical File was submitted to Yourgene's EU notified body, BSI Netherlands, who will audit it and if accepted issue a European CE Marking Certificate.
Once regulatory approvals are obtained, Yourgene plans to roll out the test "across Europe" and seek "further regulatory registrations "in newly addressable markets throughout 2020 and beyond".
The non-invasive test estimates a fetus's risk of Down's syndrome, Edwards's syndrome, and Patau's syndrome using a small blood sample from the mother's arm. The non-invasive nature of the test, means it carries no risk of miscarriage.
Yourgene Chief Executive Lyn Rees said: "We are very excited to bring our IONA test to market on the Illumina platform. The launch of the test has been greatly anticipated by our laboratory customers and will be a strong driver of our future growth. We look forward to announcing the receipt of our CE Marking certificate and updating shareholders on the plans for commercial launch."
In September 2019, Yourgene agreed an approximately GBP1 million legal settlement and licence and supply partnership agreement with Illumina Inc to resolve patent infringement litigation. Yourgene will pay Illumina a royalty for every sample tested using the IONA test, which is based on Illumina's technology.
By Anna Farley; [email protected]
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