Posted by Michael Wonder on 17 Aug 2021
Tempus submits PMA application to the FDA for its xT-Onco assay
17 August 2021 - Tempus today announced the submission of a premarket approval application for its proprietary broad-panel DNA sequencing assay to the U.S. FDA.
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, tumour profiling claims, and microsatellite instability status, using DNA isolated from formalin fixed paraffin embedded tumour tissue specimens, and matched normal specimens.
