Yourgene Health, part of the Novacyt group, has announced that its Yourgene Cystic Fibrosis Base assay has received accreditation under the new EU In Vitro Diagnostic Regulation (IVDR). This accreditation signifies that the assay meets stringent quality, safety, and performance requirements for in vitro medical devices in the European Union.
The Yourgene Cystic Fibrosis Base assay is a Class C in vitro medical device intended for use by healthcare professionals in molecular laboratories. It employs amplification-refractory mutation system technology and genetic analyzers to detect point mutations, insertions, or deletions in DNA associated with cystic fibrosis (CF).
Stringent Assessment and Compliance
The assay was assessed by the British Standards Institution (BSI), an independent conformity assessment body, and was shown to conform to the new IVDR regulations. This involved providing substantial evidence of scientific validity, as well as data demonstrating analytical and clinical performance.
Significance of Cystic Fibrosis Testing
Cystic fibrosis is a life-shortening hereditary genetic condition, affecting approximately 1 in 2,500 live births in Caucasians. Newborn screening for CF is standard practice in many countries, including the UK, where it is part of the newborn blood spot test. The Yourgene Cystic Fibrosis Base assay is designed to address various clinical scenarios, including carrier screening, newborn screening, and male factor infertility testing. The test identifies patients with any of the 50 most common CF mutations in the European population.
Industry Perspective
Lyn Rees, CEO of Novacyt, stated, "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."
Rees further added, "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."
