Tempus PMA for xT-Onco Assay

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.”