Oxford Nanopore receives regulatory approval for its first diagnostic device in the UK and Europe

Oxford Nanopore Technologies today announces that the GridION™ Dx is now both CE and UKCA marked, making it the company’s first IVD device registered in the UK and Europe. The CE and UKCA certification confirms that GridION Dx meets stringent international standards for quality, safety, and performance, positioning Oxford Nanopore for future adoption in regulated clinical markets and reflecting its long-term commitment to sequencing-based diagnostics.

“Being CE and UKCA marked for GridION Dx is an important step as we build the foundations for clinical use in regulated markets,” said Gordon Sanghera, CEO Oxford Nanopore Technologies. “This milestone demonstrates regulatory readiness and supports the deployment of GridION Dx as a diagnostic product for use in clinical environments within the UK and Europe.”

GridION Dx will initially be available through specified partnerships, with the first application being infectious disease characterisation. The Oxford Nanopore platform delivers information-rich insights and rapid time to results, in a way that is accessible and affordable – critical factors for shaping future clinical workflows and enabling expansion into areas such as oncology and genetic conditions.

The first product, available in partnership with bioMérieux, will integrate with AmPORE-TB, a multidrug-resistant tuberculosis assay, and underscores this strategic approach. bioMérieux is a world leader in the field of in vitro diagnostics recognised for its extensive portfolio of CE-marked solutions spanning microbiology, immunoassays, and molecular biology. AmPORE-TB has been introduced as a research use only (“RUO”) application and, already in clinical trials, is on a defined pathway towards a fully regulated IVD assay on GridION Dx. This underlines both companies’ commitment to bringing sequencing-based tuberculosis testing to clinical settings over time.

Dr Charles K. Cooper, Executive Vice President, Chief Medical Officer, bioMérieux stated: "The regulatory approval of GridION Dx represents a major milestone in expanding access to innovative sequencing-based solutions like AmPORE-TB. This achievement brings us closer to equipping healthcare professionals with advanced tools to combat antimicrobial resistance, enabling faster, more informed decisions and improving patient outcomes worldwide."