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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Yourgene Health Gets CE Mark for Iona NIPT Test

Yourgene Health Gets CE Mark for Iona NIPT Test

Jun 15, 2020
|
staff reporter

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.

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