Tempus xR IVD: FDA-authorized whole transcriptome RNA sequencing for Life Sciences
Overview
xR IVD1 is a FDA-authorized, next-generation sequencing-based in vitro diagnostic device that detects BRAF and RET gene rearrangements from FFPE tumor tissue specimens.
Depth of sequencing
6 million unique deduplicated reads
Platforms used
Accepted sample types
Accepted sample types
FFPE blocks or unstained slides from previously diagnosed cancer patients with solid malignant neoplasms2
Alterations identified
BRAF and RET rearrangements
Tumor type
Solid malignant neoplasms
Tumor purity requirements
20% purity required; if less than 20%, microdissection may be completed
Test design
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.
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 Percentage Agreement (PPA) | Negative Percentage Agreement (NPA) |
|---|---|---|
BRAF | 92.3% | 100% |
RET | 100% | 100% |
References
- 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.
The information on this page is intended for life sciences companies and focuses on research and development applications.
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