Tempus AI receives IVDR certification for xR assay
The certification covers Tempus' quality management system for next-generation sequencing devices for cancer genomic profiling to support clinical management.
GetSignal Tempus AI Inc TEM
Tempus AI said on October 26, 2026, that its xR assay has received certification under the European Union's In Vitro Diagnostic Regulation as a Class C in vitro diagnostic device.
According to the company, xR detects gene rearrangements and specific splice variants in solid tumor tissue to support clinical management.
Key facts
- Regulation
- European Union's In Vitro Diagnostic Regulation (IVDR)
- Device class
- Class C in vitro diagnostic device
- Assay
- xR, which detects gene rearrangements and specific splice variants in solid tumor tissue
Source: The company's release on Business Wire, October 26, 2026.
Written by GetSignal with AI from the company's press release.
Not investment advice.
