Tempus secures EU IVDR certification for its xR cancer-profiling assay

The Class C certification supports European access for an RNA-sequencing test used alongside other clinical information.

Tempus AI announced on October 26 that its xR RNA-sequencing assay had received certification under the European Union's In Vitro Diagnostic Regulation as a Class C device. The company says the certification covers its quality management system for next-generation sequencing devices used in cancer genomic profiling to support clinical management.

The xR assay detects gene rearrangements and specific splice variants in solid-tumour tissue. Tempus cites research in which combining its RNA and DNA testing improved detection of clinically actionable gene fusions compared with DNA testing alone. The certification supports continued European access and provides a certified testing platform for biopharma clinical studies.

This is a diagnostic-regulation milestone rather than a claim that an AI model independently diagnoses or treats cancer. The relevant product is a laboratory assay within a broader clinical process. Its information has to be interpreted alongside the patient's condition, other test results and the judgement of the clinical team.

The distinction helps explain why infrastructure and quality systems matter in precision medicine. An informative result is useful only when the laboratory can produce it consistently and the care team understands what it does and does not establish. Regulatory requirements formalise part of that operating foundation.

For healthcare organisations and research partners, the announcement concerns access to a defined testing service and its regulatory status. It does not establish a universal treatment benefit or an outcome for every patient. Further clinical decisions depend on the individual case, the findings returned and the available evidence for any resulting treatment choice.

Sources

- [Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling](https://investors.tempus.com/news-releases/news-release-details/tempus-receives-ivdr-certification-xr-rna-sequencing-solid-tumor) — Tempus AI