By Townhall Chicago News Staff
Chicago-based Tempus AI on Monday announced its xR assay received certification under the European Union’s In Vitro Diagnostic Regulation as a Class C in vitro diagnostic device.
The certification covers Tempus’ quality management system for next-generation sequencing devices used in cancer genomic profiling to support clinical management, according to an Oct. 26 news release from the company.
The xR platform detects gene rearrangements and specific splice variants in solid tumor tissue. A published study demonstrated that combining RNA and DNA testing increases detection of clinically actionable gene fusions compared with DNA testing alone, the company said in the release.
The IVDR certification supports continued access to the xR platform in the European Union beyond 2028, the transition deadline for eligible legacy Class C devices. It also provides pharmaceutical partners with a certified testing platform to support clinical studies in Europe, according to the release.
“Securing our European IVDR certification for xR reinforces our commitment to meeting the highest regulatory standards globally,” Lauren Silvis, senior vice president of external affairs at Tempus, said in the 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.”
Tempus, which trades on the Nasdaq under the ticker TEM, uses artificial intelligence and one of the world’s largest libraries of multimodal clinical data to advance precision medicine. The company provides AI-enabled tools to physicians and works with pharmaceutical companies on drug discovery, development and delivery.
The EU certification marks the latest in a series of regulatory milestones for the company. Tempus has previously received multiple authorizations from the U.S. Food and Drug Administration for its diagnostic platforms, including its xT CDx companion diagnostic and xR IVD products.
The announcement comes during a period of expansion for the company. Earlier in October, Tempus announced a multi-year data licensing agreement with Bristol Myers Squibb and presented research at the European Society for Medical Oncology Congress 2026 in Madrid, according to the company’s newsroom.
Tempus is headquartered in Chicago and has grown into one of the city’s most prominent health technology companies. The company’s focus on applying AI to cancer diagnostics and drug development has positioned it at the intersection of two rapidly expanding industries.
The IVDR regulatory framework governs the sale and use of in vitro diagnostic medical devices across EU member states.
Source: Tempus AI
