Yourgene Health Yourgene Cystic Fibrosis Base assay Yourgene Health (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. 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 Yourgene Cystic Fibrosis Base test was assessed by the British Standards Institution (BSI), an independent conformity assessment body, and was shown to conform to the new regulations, Cystic fibrosis (“CF”) has become the most common life-shortening hereditary genetic condition affecting 1 in 2,500 live births in Caucasians says the company. In the UK, all newborns are screened for CF as part of the newborn blood spot test.
The test is performed within the first three days of a baby's life and involves pricking the baby's heel and collecting a few drops of blood on a card. The blood is then tested for CF and other rare conditions. The Yourgene Cystic Fibrosis Base assay uses amplification-refr.