Tempus has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its xT-Onco broad-panel DNA sequencing assay.
In addition to premarket approval, 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.
The assay will be performed at Tempus' next-generation sequencing lab in Chicago.
