Key Highlights:
- 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 uses amplification-refractory mutation system technology and genetic analysers to detect point mutations, insertions or deletions in DNA.
- 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.
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Yourgene Health (part of the Novacyt group of companies), an international molecular diagnostics group, 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. 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-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.
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.
Lyn Rees, CEO of Novacyt, commented: “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. Conformity with IVDR provides clinicians and patients with additional confidence in the high-quality and accuracy of our test which is increasingly becoming an essential test in the detection and diagnosis of CF.
"CF testing is prevalent globally and there has recently been an increase in some regions due to increased reimbursement. This includes Australia where the Australian government have introduced a nationwide reimbursement pathway that enables all eligible Australians to receive CF screening either prior to, or early in pregnancy. With increasing momentum in this market, the IVDR accreditation only further validates the quality of our test within the EU and beyond.”