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xT CDx is a 648-gene tissue-based NGS-based test for molecular profiling of all solid malignant tumors, that also includes companion diagnostic (CDx) claims for colorectal cancer (CRC) patients.
| Tumor Type | Biomarker(s) Detected | Therapy |
|---|---|---|
| Colorectal cancer (CRC) | KRAS wild type (absence of mutations in codons 12 or 13) | Erbitux® (cetuximab) |
| Colorectal cancer (CRC) | KRAS wild type (absence of mutations in exons 2, 3, or 4) and NRAS wild type (absence of mutations in exons 2, 3, or 4) | Vectibix® (panitumumab) |
xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms.The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product. xT CDx is a single-site assay performed at Tempus Labs, Inc., Chicago, IL. For the complete xT CDx label, including companion diagnostic indications and important risk information, please visit tempus.com/xt-cdx-label/.
Tempus provides an established, validated platform to help reduce development time and costs associated with companion diagnostic approval.
As one of the leaders pioneering real-world data, Tempus’ robust clinico-genomic database can be used in tandem with trial sequencing data to establish control arms and compare trial data to real-world data.
6M+
de-identified research records
700K+
records with matched clinical data linked with genomic information
150K+
records with whole transcriptome profiles
Tempus has grown to be one of the largest NGS sequencers of patients’ genomic profiles in the United States.
5K+
oncologists rely on Tempus as their precision medicine partner
~50%
of all academic medical centers in the US are connected to Tempus
Tempus’ established, design-controlled, and validated platform reduces development time and costs for companion diagnostic approval.
96%
of patients matched to a clinical trial when clinical data was combined with Tempus NGS.1
Top pharmaceutical and biotech companies trust Tempus to inform therapy development. We’ve partnered with:
90%
of the top 20 pharma oncology companies
170+
biopharma partnerships
Tempus operates a CAP/CLIA certified laboratory offering NGS services that go beyond traditional lab partnerships, supporting biomarker discovery, clinical development, and diagnostics throughout the drug development process.
2 Gene expression of key immunotherapy targets,HLA typing and loss of heterozygosity, Neoantigen predictions, T-Cell/B-Cell receptor repertoire
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Read moreThis is the future of healthcare.