Tempus, a leader in artificial intelligence and precision medicine, today announced that it has CE marked its signature broad-panel genomic sequencing assay, xT. The CE marked xT test is now available for clinical use in Europe.
As part of Tempus’ broader regulatory strategy, European clinicians and their patients will benefit from Tempus’ industry-leading DNA and RNA broad-panel test already used by thousands of oncologists in the U.S. In addition to making the xT assay available for patients in the region, the CE mark will allow Tempus and its partners to expand testing for eligibility for clinical trial enrollment throughout Europe.
“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, Founder and CEO of Tempus. “We look forward to delivering our test to clinicians throughout Europe.”
Tempus’ xT platform is unparalleled in that it integrates analytics of each patient’s structured clinical data, along with molecular data from DNA sequencing and whole-transcriptome RNA sequencing. Tempus is leading the way in pairing genomic analysis and clinical data to discover unique insights that can inform treatment decisions and match patients with therapies and clinical trials based on their genomic and clinical data.
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.
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make real-time, data-driven decisions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.