Tempus has received premarket approval from the US Food and Drug Administration (FDA) for its qualitative next-generation sequencing (NGS)-based in vitro diagnostic device, xT CDx.
The xT CDx device is designed to detect substitutions (single nucleotide variants and multi-nucleotide variants), as well as insertion and deletion alterations, in a set of 648 genes.
Additionally, it can determine the microsatellite instability status in the genes using DNA extracted from formalin-fixed paraffin-embedded tumour tissue specimens.