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Earlier this year, Novigenix and collaborators were awarded up to €1 million to develop a blood-based multi-omics colorectal cancer assay.
While the guidance was welcome after years of uncertainty, regulatory experts say it does not provide enough detail for IVD manufacturers.
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.
The targeted sequencing assay analyzes 12 genes and can be paired with the firm's BRCA gene testing kit.
The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU.
IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.
The companies are developing a blood-based assay for differentiating lung cancer from benign disease in patients testing positive in low-dose CT screens.
The Finnish company also announced that it has received CE-IVD marking for its Aiforia Clinical pathology image analysis platform.
If the UK leaves the EU on Oct. 31 without a deal, the Medicines and Healthcare Products Regulatory Agency will start regulating medical devices and IVDs.
The change will be felt most immediately in Europe, where the Dutch molecular diagnostics company recently secured a CE-IVD mark for its MammaPrint BluePrint kit.