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# Tempus PMA for xT-Onco Assay
- URL: https://www.fdaweb.com/tempus-pma-for-xt-onco-assay/
- Published: 2021-08-17T12:00:00.000Z
- Updated: 2026-09-14T17:10:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149949

*Tempus has submitted a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro* diagnostic device intended to assist healthcare professionals with data-driven cancer treatment decisions. The submission includes companion diagnostic claims, tumor profiling claims, and microsatellite instability status by using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens versus matched normal specimens, according to the company. Testing will be performed at Tempus’ next-generation sequencing lab in Chicago.  

“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,” the company says. “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.”