FDA Clears Tempus AI’s RNA-Based Analytical Tool

Tempus AI Inc. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its RNA-based Tempus xR IVD device. The product will be marketed and sold as a life sciences tool to support drug development programs.

RNA sequencing captures a vast quantity of biological information and offers deeper insights into disease mechanisms, including enhanced fusion detection. RNA analysis is increasingly an important tool in research and development because it can identify molecular pathways and networks that are directly involved in disease progression.

“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. This FDA clearance further demonstrates the promise of RNA sequencing and opens up new opportunities for us with our biopharma customers,” Tempus Chief Scientific Officer Kate Sasser, Ph.D., stated. “Now, our life science partners can leverage our RNA assay to more precisely identify which patients are most likely to respond to specific therapies and to design more efficient clinical trials. As new therapeutics tied to RNA biomarkers enter the market, we believe that this assay will become even more critical for personalized treatments for patients with cancer.”

The Tempus xR IVD assay is a qualitative next generation sequencing-based in-vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detecting rearrangements in two genes, using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. Information provided by xR IVD is intended to be used by qualified healthcare professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.

The FDA authorization further solidifies Tempus as a one-stop-shop for precision medicine solutions, according to the company. Collaborators can leverage Tempus’ collection of intelligent diagnostics and growing multimodal dataset that supports therapeutic innovation. xR IVD is one of many solutions Tempus is applying to advance oncology therapeutic research and development.

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 multimodal data and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics.