Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling

What happened

Tempus AI said its xR assay received certification under the European Union's In Vitro Diagnostic Regulation as a Class C device. The certification covers its quality management system for next-generation sequencing devices used in cancer genomic profiling, and supports continued access to xR in the EU beyond 2028.

Confirmed

Global impact / market context

The certification lets Tempus keep selling xR in Europe past the 2028 deadline for older Class C devices, which means which means it protects testing revenue there. It also gives biopharma partners a certified platform for clinical studies, which could support new study contracts and wider use of its RNA tools.

Analyst inference

European rules for diagnostic tests are tightening, so certified products become a barrier to entry and an advantage for early movers. For Tempus, this supports its position against other cancer profiling providers and may help it win biopharma research work, though no financial details or sales figures were disclosed.

Analyst inference

What to watch

1. Watch whether Tempus announces new biopharma partners using the IVDR-certified xR platform for clinical studies, since the company said the certification provides such a platform. Confirmed
2. Track growth in Tempus's European testing volumes and revenue, because continued access to xR in the EU beyond 2028 depends on keeping this certification and complying with IVDR rules. Analyst inference
3. Watch for Tempus expanding its IVDR-certified RNA sequencing menu in Europe, which could broaden its addressable testing market and support capital spending on regional lab capacity. Proposed

Evidence

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