Tempus AI (TEM) announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its RNA-based Tempus xR IVD device. The company stated xR IVD will be offered as a life sciences tool to support drug development programs. The assay is a qualitative next-generation sequencing-based in vitro diagnostic device for the detection of rearrangements in two genes, using RNA isolated from tumor tissue specimens from patients with solid malignant neoplasms.
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