Yourgene Health Cystic Fibrosis assay receives IVDR accreditation

The Yourgene^® Cystic Fibrosis Base assay uses amplification-refractory mutation system technology and genetic analysers 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.

In the UK, all new-borns are screened for cystic fibrosis (CF) as part of the new-born 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 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.

IVDR ensures that the Yourgene Cystic Fibrosis Base test, 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 test was assessed by the British Standards Institution (BSI), an independent conformity assessment body, and was shown to conform to the new regulations.

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