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Tempus xR IVD
Whole transcriptome RNA sequencing panel
xR IVD1 is a next-generation sequencing-based in vitro diagnostic device that detects BRAF and RET gene rearrangements from FFPE tumor tissue specimens.
Assay specifications
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Alterations identified
BRAF and RET rearrangements.
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Tumor type
Solid malignant neoplasms.
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Depth of sequencing
6 million unique deduplicated reads.
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Platforms used
Illumina NovaSeq 6000.
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Accepted sample types
FFPE blocks or unstained slides from previously diagnosed cancer patients with solid malignant neoplasms.2
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Tumor purity requirements
20% purity required. If less than 20%, microdissection may be completed.
The Tempus xR IVD assay is a qualitative, next-generation sequencing-based in vitro diagnostic device that uses targeted, high-throughput, hybridization-based capture technology to detect rearrangements in two genes using RNA isolated from Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms.
Information provided by xR IVD is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Results from xR IVD are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product.
xR IVD Technical Information (FDA Label)TEMPUS xR IVD PERFORMANCE SPECIFICATIONS—CHICAGO LAB
The xR IVD assay has demonstrated accuracy for detecting gene rearrangements when compared to an externally validated, orthogonal next-generation sequencing (NGS) method.
| Gene Rearrangements | Positive Percent Agreement (PPA) | Negative Percent Agreement (NPA) |
|---|---|---|
| BRAF | 92.3% | 100% |
| RET | 100% | 100% |
Comprehensive solutions for every stage of clinical development
See our full suite of NGS assays.
- The Tempus xR IVD assay is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of rearrangements in two genes using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. Information provided by xR IVD is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Results from xR IVD are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product. For the complete xR IVD label, including intended use, limitations, and important risk information, please visit tempus.com/xr-ivd-label/.
- Archival paraffin embedded material subjected to acid decalcification is unsuitable for analysis.
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