xT CDx is an FDA-approved NGS test for molecular profiling of all malignant solid tumors. It includes 648 genes for detecting substitutions, insertions, deletions, and MSI status. The test aids in identifying patients for treatment with targeted therapies and provides tumor mutation profiling. It is used in accordance with professional oncology guidelines for previously diagnosed cancer patients with solid malignant neoplasms.
Special Instructions
The test offers a comprehensive genomic analysis which includes tumor mutational burden, HLA Class I genotyping, CNVs, and therapy matching insights. Ordering can be done via Tempus Hub, paper requisition, or EHR. Auto-conversion to liquid biopsy in case of insufficient tissue is available. Specific instruments are used for performing the test in-house at Tempus Labs, Chicago.
Limitations
xT CDx requires FFPE-prepared tumor tissue specimens and matched normal blood or saliva. It is not intended for germline variant reporting. A minimum tumor percentage of 20% is necessary to detect variants, 30% for MSI. The performance is not established for insertions or deletions larger than 25 base pairs. A negative result does not eliminate the possibility of mutations below the detection limit. MSI status is derived from genome-wide analysis, which may not correlate with current guidelines.
Methodology
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Related Documents
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Collection Instructions
Causes for Rejection