Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling
Tempus AI received EU IVDR certification for its xR RNA sequencing assay as a Class C in vitro diagnostic device for solid tumor profiling. The certification covers the company's quality management system for next-generation sequencing devices used in cancer genomic profiling and secures continued EU access to xR beyond the 2028 transition deadline for legacy Class C devices. It also gives biopharma partners an IVDR-certified testing platform for clinical studies, reinforcing Tempus' European regulatory foundation.
Key figures
- Ivdr class
- Class C
- Eu transition deadline
- 2028
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