FDA-approved companion diagnostic

xT CDx

Comprehensive NGS-based companion diagnostic that detects somatic and germline variants across hundreds of genes in FFPE tumors and matched normal samples to guide targeted therapy

Lab-developed CDxMethod: NGSSpecimen: Tissue (FFPE)Biomarker: Multi-gene tumor genomic alterations
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P210011
Supplements
Manufacturer
Tempus
Approval date
April 28, 2023
Test specifications
Methodology
NGS
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
Multi-gene tumor genomic alterations
What this test is

xT CDx is an FDA-approved, hybrid-capture next-generation sequencing assay that analyzes DNA and RNA from FFPE tumor tissue and matched normal blood to detect substitutions, insertions, deletions, copy number changes, and fusions across hundreds of cancer-related genes. It provides comprehensive genomic profiling to determine actionable biomarkers and support precision treatment planning.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Colorectal Cancer (CRC)KRASKRAS wild-type (absence of mutations in codons 12 and 13)ERBITUX
KRAS and NRASwild-type (absence of mutations in exons 2, 3 and 4)VECTIBIX

Performing lab

Tempus

Chicago (14D2114007)

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com. 

Order this test

If your organization is connected to Casandra, you can place an electronic order forxT CDx directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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