(Alliance News) - Molecular diagnostics company Yourgene Health PLC said on Thursday that it has transferred its quality accreditation process to a new notified body, BSI NL.
The move, in preparation for a 2020 product launch and as a contingency for Brexit, will allow the company to continue to sell its systems in the European Economic Area.
As part of this transfer, Yourgene has been issued with a renewed CE-IVD Certificate from BSI NL covering the design and manufacture of its IONA test. Under the new certification, the company's CE-IVD mark will be valid until 25 January, 2021.
"The smooth and successful transfer to our new notified body in the Netherlands is a testament to the regulatory team at Yourgene and to the robust systems we have in place for quality assurance. The move to BSI NL is a key part of our Brexit contingency planning and also prepares us for the launch of our new Illumina-based version of the IONA test from early next year," said Chief Execuive Lyn Rees.
Yourgene Health shares were down 1.0% at 12.25 pence in London on Thursday.
By Lucy Heming; lucyheming@alliancenews.com
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