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Yourgene Health Receives IVDR Accreditation for Cystic Fibrosis Base Assay

NextEdge Admin

18 Oct 2024

2 min 20 sec

Yourgene Health, part of the Novacyt group, has announced that its Cystic Fibrosis Base assay has achieved accreditation under the new EU In Vitro Diagnostic Regulation (IVDR). This Class C in vitro diagnostic device, designed for use in molecular laboratories, meets rigorous quality, safety, and performance standards required under IVDR.

The assay was independently evaluated by the British Standards Institution (BSI) to demonstrate its scientific validity and clinical performance. It uses amplification-refractory mutation system (ARMS) technology and genetic analysers to detect point mutations, insertions, or deletions in DNA. The test supports multiple diagnostic applications, including carrier screening, newborn screening, and male infertility testing, by identifying the 50 most common cystic fibrosis (CF) mutations in the European population.

CF is a life-limiting hereditary condition, affecting 1 in 2,500 live births among Caucasians. In the UK, CF screening is part of the newborn blood spot test performed within the first three days of life.

Lyn Rees, CEO of Novacyt, highlighted the significance of the accreditation, stating that the assay is one of the first CF tests to comply with the IVDR. He noted that compliance offers clinicians and patients greater confidence in the test’s accuracy and quality. Globally, CF testing is gaining momentum, especially in regions like Australia, where new reimbursement pathways now provide broader access to early CF screening. The IVDR certification further solidifies the test’s standing in the EU and supports international growth opportunities.