NEW YORK – Novacyt subsidiary Yourgene Health said Thursday that its Yourgene Cystic Fibrosis Base assay has received accreditation under the European Union's In Vitro Diagnostic Regulation as a Class C in vitro medical device.
The test was assessed by the British Standards Institution (BSI), an independent conformity assessment body, and shown to adhere to the new regulatory requirements, according to the firm. It utilizes amplification-refractory mutation system (ARMS) technology and genetic analyzers to detect point mutations, insertions, and deletions in DNA, focusing on the 50 most common cystic fibrosis mutations in European ancestry populations. The assay can be deployed in carrier screening, newborn screening, and male factor infertility testing.
"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," Novacyt CEO Lyn Rees said in a statement. "With increasing momentum in this market, the IVDR accreditation only further validates the quality of our test within the EU and beyond."
The assay is compatible with most commonly used DNA extraction protocols, thermal cyclers, and capillary electrophoresis instruments, according to Yourgene's website. It provides results in about five hours.