Yourgene Health Cystic Fibrosis Base assay receives IVDR accreditation
Yourgene Health 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 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-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, 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.
