Yourgene Health, part of the Novacyt group, has announced that it has received accreditation for its Yourgene® Cystic Fibrosis Base assay under the new European Union in vitro diagnostic regulation (IVDR). This assay is classified as a Class C in vitro medical device and is intended for use by healthcare professionals in molecular laboratories.
The IVDR ensures that the Yourgene Cystic Fibrosis Base test meets strict quality, safety, and performance standards for products sold in the EU. Manufacturers must provide substantial evidence of scientific validity and data showing both analytical and clinical performance. The test was assessed by the British Standards Institution (BSI), an independent body that confirmed its compliance with the new regulations.
Cystic fibrosis (CF) is now the most common life-shortening genetic condition, affecting 1 in 2,500 live births among Caucasians. In the UK, newborns are screened for CF as part of the newborn blood spot test. This test is typically conducted within the first three days of life and involves a heel prick to collect a few drops of blood. This blood is then tested for CF and other rare conditions.
The Yourgene Cystic Fibrosis Base assay uses advanced technology to detect genetic mutations associated with CF. It is designed for various diagnostic situations, including carrier screening, newborn screening, and testing for male factor infertility. This test is part of Yourgene’s Reproductive Health portfolio and identifies patients with any of the 50 most common CF mutations in the European population.
CF testing is widely conducted around the world, with a recent surge in demand in some regions due to increased reimbursement policies. In Australia, the government has introduced a nationwide reimbursement pathway for CF screening, allowing eligible Australians to access testing before or early in pregnancy. Yourgene’s IVDR accreditation reinforces the quality of its test in the EU and other markets.
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