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Tempus receives FDA approval for NGS-based test xT CDx

May 2, 2023

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.

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