Tempus secures EU IVDR certification for its xR RNA sequencing tumour test

Tempus AI has won certification for its xR RNA sequencing assay under the European Union's In Vitro Diagnostic Regulation (IVDR), classed as a Class C in vitro diagnostic device. The Nasdaq-listed company announced the certification on 26 October.

What xR does

xR reads RNA from solid tumour tissue to find gene rearrangements and specific splice variants. These are changes that DNA-only panels can miss, and several of them point to targeted cancer drugs. Tempus cites a published study showing that running its RNA and DNA tests together picks up more clinically actionable gene fusions than DNA testing on its own.

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The certification also covers Tempus's quality management system for next-generation sequencing devices used in cancer genomic profiling to support clinical management. In plain terms, regulators have signed off both the test and the processes behind it.

Why IVDR matters

IVDR has been one of the hardest regulatory shifts in diagnostics in years. Tests that were on the market under the old European rules have to be brought up to the new standard within transition periods, and the higher a test's risk class, the closer the scrutiny it gets. Tempus says this certification keeps xR available in the EU beyond 2028, the transition deadline for eligible legacy Class C devices.

"Securing our European IVDR certification for xR reinforces our commitment to meeting the highest regulatory standards globally." Lauren Silvis, SVP of External Affairs, Tempus

Tempus frames the certification as a base for widening access to its RNA sequencing tools for European doctors, drug developers and patients. It did not name the notified body, give a launch timetable for new European customers, or share volume figures.

The pharma angle

For biopharma, the more immediate benefit may be in clinical trials. Sponsors running studies in Europe need testing that meets local rules, and an IVDR-certified assay removes one obstacle to using Tempus for patient selection and biomarker work on European sites.

The bigger picture

For US genomic testing companies, Europe has often been a market where the science travels well but the regulation and reimbursement do not. Each IVDR certificate lowers that barrier for the company that holds it, and raises it for competitors still working through the process.

What it means for hiring

IVDR certification is usually followed by a push to build in-market teams. In our view, people who combine European oncology sales experience with knowledge of NGS testing will be in short supply.
Regulatory affairs and quality specialists with hands-on IVDR experience remain among the hardest diagnostics hires in Europe. Every company that gets through the process makes the next one keener to hire people who have done it.
Pharma services teams that can sell an EU-certified assay into trial sponsors become more valuable, so expect demand for biopharma business development leaders with a European network.

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