Cancer: Tempus AI xRNA sequencing test obtains European Class C IVDR certification

The test detects BRAF and RET gene rearrangements in solid tumours; DNA-associated RNA sequencing increases patients' access to targeted therapies by 24%.

Tempus AI announced on 26 October that its RNA sequencing test xR IVD has received Class C certification under the European Regulation on in vitro diagnostic devices (IVDR), which also covers its quality management system for new generation genomic profiling devices for cancer by sequencing.

Test identifies gene rearrangements BRAF and RETURN as well as certain splicing variants in solid tumour samples. It works by targeted capture on the Illumina NovaSeq 6000 platform and requires a tumour purity of at least 20%. Its announced performance: 92.3% positive match and 100% negative match for BRAF, 100% in both cases for RET.

A retrospective study of approximately 80,000 samples from 77,400 patients showed that 29.1% of gene fusions were only visible during RNA sequencing, and that combining RNA and DNA increased the number of patients eligible for targeted therapy by 24%. The certification secures Tempus' access to the European market before the deadline of 31 December 2028 laid down for existing Class C devices.