Tempus AI, Inc. (NASDAQ:TEM) stock climbed 5% on Monday after the company announced it received 510(k) clearance from the U.S. Food and Drug Administration for its RNA-based Tempus xR IVD device.
The AI-driven precision medicine company will offer the newly cleared device as a life sciences tool to support drug development programs. The Tempus xR IVD assay is a qualitative next-generation sequencing in vitro diagnostic that detects rearrangements in two genes using RNA extracted from tumor tissue specimens.
RNA sequencing provides deeper insights into disease mechanisms, including enhanced detection of gene fusions, which can be especially valuable in cancer research. The technology captures biological information that goes beyond DNA analysis alone.
“We have long known that RNA sequencing offers additional insights beyond DNA alone, but only now are we beginning to unlock its full value in supporting therapeutic development,” said Kate Sasser, PhD, Chief Scientific Officer at Tempus. “This FDA clearance further demonstrates the promise of RNA sequencing and opens up new opportunities for us with our biopharma customers.”
The company highlighted that life science partners can now use the RNA assay to more precisely identify patients likely to respond to specific therapies and design more efficient clinical trials. Tempus anticipates that the assay will become increasingly important for personalized cancer treatments as new therapeutics linked to RNA biomarkers emerge.
This FDA authorization reinforces Tempus AI’s role as a comprehensive provider of precision medicine solutions, giving collaborators access to its diagnostic tools and multimodal dataset to drive therapeutic innovation.