Chicago-based artificial intelligence and precision medicine company Tempus announced this week it has received a CE designation for, xT, its broad-panel genomic sequencing test. The panel, which is already being used by oncologists in the U.S., will not only make the test available to clinicians in Europe, but will also allow for expanded testing of patients in the region for clinical trial matching and enrollment.
“Tempus’ leading next generation sequencing assay has been widely adopted by oncologists across the U.S. as it provides the most comprehensive molecular profiling in the market along with insights derived from clinical context, uniquely enabling physicians to deliver truly personalized care to their patients,” said Eric Lefkofsky, Tempus founder and CEO in a press release. “We look forward to delivering our test to clinicians throughout Europe.”
The Tempus xT assay is a targeted panel of 684 clinically relevant genes and most commonly mutated cancer driver genes. It also includes additional genes of emerging clinical significance focused on immediately actionable mutations. The test is enhanced further via the xT platform which integrates each patient’s structured clinical data with the DNA and whole-transcriptome RNA data delivered by the assay. According to the company, the pairing of clinical and molecular data can provide “unique insights” that allow for both more targeted treatments and matching of patients with active, relevant clinical trials.
The xT assay is CE marked under the In Vitro Diagnostic Devices Directive (98/79/EC) for detection of somatic single nucleotide variants (SNVs) and insertion and deletion alterations (indels) using DNA in 648 genes, as well as detection of fusions using RNA whole-transcriptome sequencing, in solid tumors.