Registered as an in-vitro diagnostic medical device with the Medicines and Healthcare Products Regulatory Agency (MHRA), the assay is commercialised with a UKCA marker.
It is validated and has UKAS ISO 15189 accreditation.
We are working towards further regulatory approvals, such as EU IVDR and USA FDA 510K.
If you are a lab outside of the UK and would like to support these developments please get in touch using the button below.
Patents
The MSI-plus assay has a pending patent application, with the following publication details: Patent Pending. Covered by U.S. Patent Publication No. US-2025-0305054-A1. For more information please visit Patent Public Search Basic | USPTO.
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