Home > Our products > Newcastle MSI-plus assay – test for lynch syndrome > Regulatory approvals

Regulatory approvals

Registered with the MHRA and validated with UKAS accreditation.

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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, to support laboratories outside of the UK and bring the MSI-plus assay to these new applications.

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