Tempus AI Secures EU Class C Certification for xR RNA Cancer Profiling Assay

Tempus AI said on Monday, October 26, that its xR RNA sequencing assay had received Class C certification under the European Union's In Vitro Diagnostic Regulation (IVDR), a regulatory step for its cancer molecular-profiling business.

The Chicago-based company said the certification also covers its quality-management system for next-generation sequencing devices used in cancer genomic profiling. Its xR assay is designed to detect gene rearrangements and particular splice variants in tissue from solid tumours, information that can support clinical assessment.

The certification is relevant to the EU's transition to stricter rules for in vitro diagnostic devices. Tempus said it supports continued availability of xR beyond 2028, the transition deadline for eligible legacy Class C devices. The company also said pharmaceutical and biotechnology partners could use the certified platform in clinical studies.

The regulatory announcement does not establish that the assay improves survival or other patient outcomes. Detection of molecular features and evidence that using a test changes treatment outcomes are different questions. Independent coverage also noted that Tempus had not announced a new country launch, reimbursement agreement or European sales target alongside the certification.

The company cited earlier research indicating that combined RNA and DNA analysis can identify some clinically actionable gene fusions that DNA analysis alone may miss. Those findings should not be interpreted as a direct estimate of the newly certified assay's standalone clinical performance.

The development adds a regulatory credential for an existing diagnostic offering rather than announcing a new medicine or a change to treatment guidelines. Tempus has not disclosed a financial forecast specifically attributable to the European certification.