Yourgene Health, part of the Novacyt group, has received accreditation for their Yourgene Cystic Fibrosis Base assay under the new EU IVDR requirements. The test is a Class C in vitro medical device intended for use in molecular laboratory environments by healthcare professionals. The accreditation ensures that the test meets stringent quality, safety, and performance standards. Cystic fibrosis is a common genetic condition affecting 1 in 2,500 Caucasians and newborns in the UK are screened for it. The Yourgene test uses advanced technology to detect CF mutations and is part of the company’s Reproductive Health portfolio. The accreditation provides confidence in the test’s quality and accuracy for CF detection.
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Yourgene Health advances cystic fibrosis testing with IVDR compliance
