Yourgene Health, a leading international molecular diagnostics group that is part of the Novacyt group of companies, has announced that it has received accreditation under the new EU requirements of the in vitro diagnostic regulation (IVDR) for the Yourgene® Cystic Fibrosis Base assay. The Yourgene Cystic Fibrosis Base assay is a Class C in vitro medical device under IVDR and is intended for use by healthcare professionals within a molecular laboratory environment.
The IVDR ensures that the Yourgene Cystic Fibrosis Base test, which is manufactured for sale in the EU, is assessed against stringent quality, safety, and performance requirements. Manufacturers must provide considerable evidence of scientific validity, as well as data demonstrating analytical and clinical performance of the tests. The British Standards Institution (BSI), an independent conformity assessment body, assessed the Yourgene Cystic Fibrosis Base test and found that it conforms to the new regulations.
Cystic fibrosis is the most common life-shortening hereditary genetic condition affecting 1 in 2,500 live births in Caucasians. In the UK, all newborns are screened for CF as part of the newborn blood spot test. The Yourgene Cystic Fibrosis Base assay uses amplification-refractory mutation system technology and genetic analyzers to detect point mutations, insertions, or deletions in DNA. The assay is designed with all clinically relevant diagnostic scenarios in mind, such as carrier screening, newborn screening, and male factor infertility testing.
The Yourgene Cystic Fibrosis Base test, which is part of Yourgene’s Reproductive Health portfolio, is used to identify patients with any of the 50 most common CF mutations in the European population. The IVDR accreditation provides clinicians and patients with additional confidence in the high-quality and accuracy of the test, which is increasingly becoming an essential test in the detection and diagnosis of CF.
Lyn Rees, CEO of Novacyt, commented that this is the second product within the now enlarged Novacyt product portfolio to conform to the new EU IVDR regulations and is one of the first IVDR CF tests on the market. With increasing momentum in the CF testing market, the IVDR accreditation only further validates the quality of their test within the EU and beyond
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