NEW YORK – AI precision medicine firm Tempus said on Tuesday that it has obtained the CE mark for its cancer genomic sequencing assay, xT, making the test available for clinical use in Europe and other countries that accept the designation.
According to the company, the xT assay is already used by thousands of oncologists in the US, and broadening availability to European clinicians is part of the firm's regulatory strategy.
In addition to making the test available for patients in the region, the CE mark also allows Tempus and its partners to expand its adoption for local clinical trial enrollment.
Tempus Founder and CEO Eric Lefkofsky said in a statement that the xT test provides some of the most comprehensive molecular profiling in the market, with added insights derived from clinical context.
The company's xT platform integrates a patient’s structured clinical data with molecular data from DNA and RNA sequencing of solid tumors. Specifically, it detects somatic single nucleotide variants, insertions, and deletions from DNA sequencing across 648 genes, as well as gene fusions using RNA whole-transcriptome sequencing.