The assay detects gene rearrangements and splice variants in solid tumors, with certification supporting continued access in the EU beyond the 2028 transition deadline.
Tempus AI announced that its xR assay has received certification under the European Union’s In Vitro Diagnostic Regulation (IVDR) as a Class C in vitro diagnostic device.
The certification covers the company’s quality management system for “next-generation sequencing devices for cancer genomic profiling to support clinical management.”
The xR assay is designed to detect gene rearrangements and specific splice variants in solid tumor tissue to guide clinical decision-making. According to the company, a published study demonstrated that combining Tempus RNA and DNA testing increases the detection of clinically actionable gene fusions compared with DNA testing alone.
Ensuring Diagnostic Access Beyond 2028
The IVDR certification supports uninterrupted access to the xR assay in the EU beyond 2028, the transition deadline established for eligible legacy Class C in vitro diagnostic devices.
In addition to clinical utility, the certification provides biopharma collaborators 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,” says Lauren Silvis, senior vice president of external affairs at Tempus, in a release. “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.”
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