The certification covers Tempus’ quality management system for "next-generation sequencing devices for cancer genomic profiling to support clinical management."

xR detects gene rearrangements and specific splice variants in solid tumor tissue to support clinical management. A published study demonstrated that combining Tempus RNA and DNA testing increases detection of clinically actionable gene fusions compared with DNA testing alone.

IVDR certification supports continued access to xR in the EU beyond 2028, the transition deadline for eligible legacy Class C devices, and provides biopharma partners with an IVDR-certified testing platform to support clinical studies.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.