EU
The year saw the resolution of pressing issues around how IVDs will be regulated in Europe, including the UK, in the future.
European Union to Review Illumina's Planned Grail Acquisition Under New Guidance
Illumina reaffirmed its commitment to the $8 billion deal and said it does not believe the European authorities have jurisdiction to review it.
Novigenix-Led Consortium Awarded Up to €1M to Develop Predictive Immune Checkpoint Inhibitor Test
Earlier this year, Novigenix and collaborators were awarded up to €1 million to develop a blood-based multi-omics colorectal cancer assay.
Experts See Negatives, Positives in Proposed Post-Brexit UK IVD Regulations
While the guidance was welcome after years of uncertainty, regulatory experts say it does not provide enough detail for IVD manufacturers.Â
UK's MHRA Issues Guidance on Post-Brexit IVD Regulations
IVDs in the future will require certification in England, Scotland, and Wales, while companies will still be able to sell tests in Northern Ireland under existing EU regulations.