On August 17, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported the submission of a Premarket Approval (PMA) application for its proprietary broad-panel DNA sequencing assay to the U.S. Food and Drug Administration (FDA).
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Tempus is seeking approval for its xT-Onco assay, a broad-panel next-generation sequencing-based, in vitro diagnostic device. The submission includes companion diagnostic claims, tumor profiling claims, and microsatellite instability status, using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens, and matched normal specimens. Tempus xT-Onco will be performed at Tempus’ next-generation sequencing lab in Chicago.
"Oncologists throughout the country leverage Tempus’ sequencing assays to inform data-driven treatment decisions and deliver personalized patient care," said Lauren Silvis, Senior Vice President, Regulatory Affairs at Tempus. "This regulatory milestone demonstrates our commitment to expanding the promise of precision medicine in oncology to more patients and providers."
The PMA submission builds on Tempus’ existing precision medicine platform, adding the regulatory component to provide a comprehensive suite of solutions for novel drug development programs. Sponsors can leverage Tempus’ next-generation sequencing platform, clinical trial matching capabilities and its vast library of clinical and molecular data to support therapeutic innovation. The combination of these components, along with Tempus’ advanced artificial intelligence capabilities, distinguishes Tempus’ unique approach to precision medicine.