www.fdanews.com/articles/204680-genedrive-system-mutation-screening-platform-gets-ce-mark
Genedrive System Mutation Screening Platform Gets CE Mark
October 5, 2021
UK-based molecular diagnostics company Genedrive’s new Genedrive system platform, which supports the company’s MT- RNR1 ID kit, has received a CE-IVD mark certification.
The Genedrive MT- RNR1 assay is used to screen for a genetic mutation which can cause deafness in a baby given the common antibiotic gentamicin. The test allows for the administration of alternative treatments when the mutation is found.
Genedrive said the newly certified platform includes improvements to make it more user-friendly, based on feedback from a study sponsored by the company. The assay is now being rolled out in the EU and the UK.