Press release summary
Tempus AI said its xR RNA sequencing assay has received certification as a Class C in vitro diagnostic device under the European Union’s In Vitro Diagnostic Regulation. The certification covers the company’s quality management system for next-generation sequencing devices used in cancer genomic profiling to support clinical management.
The xR assay analyzes RNA from solid tumor tissue to detect gene rearrangements and selected splice variants. Tempus says combining RNA and DNA testing can identify clinically actionable gene fusions that DNA-only testing may miss. The company also said the certification supports continued access to xR in the European Union beyond the 2028 transition deadline for eligible legacy Class C devices and makes the platform available for use in biopharma clinical studies.
For molecular laboratories, the development is significant because IVDR compliance reaches beyond assay performance. It requires documented quality systems, risk management, performance evidence, and post-market controls. Certification can therefore affect how laboratories plan validation, supplier qualification, regulatory documentation, and continuity of testing across European sites. The announcement did not include new clinical outcome data.
Original release: Tempus AI, Oct. 26, 2026.
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