RNA Sequencing Assay Gains EU Certification for Solid Tumor Profiling

Combining RNA and DNA testing can identify more clinically actionable gene fusions than DNA testing alone. To support these workflows, a newly certified assay provides an RNA sequencing option under European diagnostic regulation.

The Tempus xR assay from Tempus AI, Inc. (Chicago, IL, USA) has received certification under the European Union’s In Vitro Diagnostic Regulation (IVDR) as a Class C in vitro diagnostic device. Designed for solid tumor tissue analysis, the assay supports cancer genomic profiling for clinical management. The certification also covers Tempus’ quality management system for next-generation sequencing devices used in this setting.

Within this profiling workflow, xR detects gene rearrangements and specific splice variants in solid tumor tissue using RNA sequencing as part of a next-generation sequencing approach. Evidence supporting the combination of RNA and DNA analysis comes from a published study cited for the assay, which showed that combined Tempus RNA and DNA testing increases detection of clinically actionable gene fusions compared with DNA testing alone.

The IVDR certification supports continued access to xR in the European Union beyond 2028. That year is the transition deadline for eligible legacy Class C devices. The certification also provides biopharma partners with an IVDR-certified testing platform to support clinical studies.

“Securing our European IVDR certification for xR reinforces our commitment to meeting the highest regulatory standards globally. This achievement establishes a strong regulatory foundation in Europe as we work to expand access to our advanced RNA sequencing tools for healthcare providers, biopharma partners and cancer patients across the region,” said Lauren Silvis, SVP of External Affairs at Tempus.