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.