Yourgene Health improves cystic fibrosis testing in line with IVDR

Yourgene Health (part of the Novacyt group of companies), a leading international molecular diagnostics group, announces that it has been accredited under recent EU requirements in vitro diagnostic regulation (IVDR) for cystic fibrosis Yourgene® Resist analysis. Yourgene cystic fibrosis Resist the test belongs to class C in vitro a medical device covered by the IVDR Directive and intended for utilize by healthcare professionals in a molecular laboratory environment.

IVDR ensures that Yourgene Cystic Fibrosis Resist The test, which is produced for sale in the EU, is assessed against strict quality, safety and performance requirements. Manufacturers must provide substantial evidence of scientific validity, as well as data demonstrating the analytical and clinical performance of the tests. Yourgene cystic fibrosis Resist the test has been assessed by the British Standards Institution (BSI), an independent conformity assessment body, and has demonstrated compliance with the recent regulations,

Cystic fibrosis (“CF”) has become the most common life-shortening inherited genetic disease, occurring in 1 in 2,500 live births in Caucasians. In the UK, all newborns are screened for cystic fibrosis as part of the newborn blood spot test. The test is performed during the first three days of the child’s life and involves pricking the child’s heel and taking a few drops of blood onto a card. The blood is then tested for cystic fibrosis and other sporadic diseases. Yourgene cystic fibrosis Resist The test uses amplification-resistant mutation system technology and genetic analyzers to detect point mutations, insertions or deletions in DNA. The test was designed to take into account all clinically relevant diagnostic scenarios, such as carrier screening, newborn screening and male factor infertility testing.

Yourgene cystic fibrosis Resist the 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 in Novacyt’s expanded product portfolio that is compliant with the recent EU IVDR regulations and is one of the first IVDR CF tests on the market. IVDR compliance gives clinicians and patients additional confidence in the high quality and accuracy of our test, which is increasingly becoming an crucial test in the detection and diagnosis of cystic fibrosis.

_CF testing is common around the world and has recently seen an enhance in some regions due to increased reimbursement. This includes Australia, where the Australian Government has introduced a nationwide reimbursement pathway that enables all eligible Australian women to be screened for CF before or at the beginning of pregnancy. As this market becomes more animated, IVDR accreditation further confirms the quality of our test in the EU and beyond.