Tempus AI, Inc. , a leader in applying artificial intelligence to precision medicine, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RNA-based Tempus xR IVD device. The newly authorized assay will be offered as a life sciences tool to accelerate drug development programs.
RNA sequencing provides a broad spectrum of biological insights and enhances understanding of disease mechanisms, particularly through improved fusion detection. Increasingly, RNA analysis is being adopted in R&D to map molecular pathways and networks 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.
She added, “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 is a qualitative next-generation sequencing (NGS)-based in vitro diagnostic device that employs hybridization-based capture technology to detect rearrangements in two genes. It uses RNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms.
The assay is intended for use by qualified healthcare professionals, in line with professional oncology guidelines, to provide additional insights for patients with diagnosed solid tumors. Importantly, results are not prescriptive or conclusive for the labeled use of any specific therapeutic product.
With this FDA clearance, Tempus reinforces its position as a comprehensive precision medicine partner, offering a suite of intelligent diagnostics backed by its expanding multimodal dataset. The xR IVD assay adds to the company’s growing portfolio of solutions designed to accelerate oncology therapeutic research and development.