Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling
Business Wire•26/10/2026•08:30 ET
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Key Highlights
- ➤Tempus’ xR assay receives EU IVDR Class C certification for solid tumor profiling
- ➤Certification supports continued EU xR access beyond 2028 transition deadline
- ➤IVDR certification provides biopharma partners a platform for clinical studies
- ➤Tempus RNA plus DNA testing increases detection of actionable gene fusions versus DNA alone
Expert Statements
Lauren Silvis, SVP of External Affairs at Tempus
“Securing our European IVDR certification for xR reinforces our commitment to meeting the highest regulatory standards globally.”
Lauren Silvis, SVP of External Affairs at Tempus
“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.”
Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling
Tempus AI, Inc. (NASDAQ: TEM) today 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 Tempus’ quality management system for "next-generation sequencing devices for cancer genomic profiling to support clinical management."
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