Tempus Receives U.S. FDA 510(k) Clearance for Tempus xR IVD, its RNA NGS In Vitro Diagnostic Device

Original from: business wire

Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RNA-based Tempus xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs.

RNA sequencing captures a large array of biological information and offers deeper insights into the mechanisms of diseases, 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,” said Kate Sasser, PhD, Chief Scientific Officer at Tempus. “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 detection of 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 health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Results from xR IVD are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product.

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

Source: Tempus Receives U.S. FDA 510(k) Clearance for Tempus xR IVD, its RNA NGS In Vitro Diagnostic Device