Technology company Tempus AI Inc (NASDAQ: TEM) revealed on Monday that it has received U.S. Food and Drug Administration 510(k) clearance for its RNA-based Tempus xR IVD device, a next generation sequencing in vitro diagnostic tool designed to support drug development.

The Tempus xR IVD assay uses targeted hybridisation-based capture technology to detect gene rearrangements in RNA isolated from FFPE tumour tissue in patients with solid malignant neoplasms. The results are intended to aid qualified healthcare professionals in oncology research but are not prescriptive for specific therapeutic products.

RNA sequencing enables enhanced fusion detection and deeper insights into disease mechanisms, making it a key tool for identifying molecular pathways in drug discovery and development.

Tempus said the clearance strengthens its position as a comprehensive precision medicine provider, offering intelligent diagnostics and leveraging one of the world's largest multimodal datasets to advance oncology research and therapeutic innovation.