xT CDx
Tempus Labs, Inc.The Tempus xT CDx is a genetic sequencing test designed to detect specific mutations and microsatellite instability in solid tumor tissue samples. It helps clinicians identify patients who may benefit from targeted cancer therapies, particularly in colorectal cancer, by analyzing tumor DNA and matched normal blood or saliva samples. The test uses advanced sequencing technology to deliver accurate tumor mutation profiling and companion diagnostics for personalized cancer treatment.
Intended Use
xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations in 648 genes and MSI status from FFPE tumor tissue and matched normal blood or saliva specimens in patients with solid malignant neoplasms, intended for companion diagnostic use and tumor mutation profiling.
Technology
The device uses whole-genome shotgun library construction, hybridization-based capture of 648 cancer-related genes and 239 MSI loci, followed by sequencing on an Illumina NovaSeq 6000 platform. It includes automated data analysis pipelines for variant calling (SNVs, MNVs, INDELs) and MSI classification, integrating curated databases for clinical interpretation. Specimens require minimum 20% tumor purity. Quality control steps occur at multiple stages including sequencing quality, sample provenance, and PCR duplication rates.
Performance
Performance testing demonstrated high analytical accuracy and precision for detecting 1028 unique variants across 31 tumor types with 99.1% positive percent agreement (PPA) and 100% negative percent agreement (NPA) compared to orthogonal methods. MSI detection showed 94% PPA and 98% NPA versus IHC. Clinical concordance studies with Praxis and therascreen CDx assays confirmed non-inferiority with ≥99.6% overall concordance for colorectal cancer samples. Sample stability, interference, guardbanding, and reagent stability studies confirmed robust performance. Pass rates for QC steps exceeded 90%.
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