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Yourgene Health Gets CE Mark for Iona NIPT Test

NEW YORK – Yourgene Health announced Monday it has received CE-IVD marking for its Illumina-based Iona noninvasive prenatal test for genetic disorders including Down's syndrome.

The Iona Nx NIPT Workflow was developed to run on Illumina's NextSeq 550Dx next-generation sequencing platform and has a new workflow featuring advanced proprietary sample preparation technologies and a simplified test process to reduce the need for instrumentation capital expenditure, the company said in a statement.

Manchester, UK-based Yourgene is planning to roll the test out to laboratory customers in the UK and Europe in the next few months, along with establishing a laboratory-based test service at its Manchester lab.