Loading
A tumour RNA sequencing test from Tempus, usually run with its DNA panel, that finds gene fusions DNA testing can miss.
The FDA cleared xR IVD (510(k) K241868, Tempus AI) on 19 September 2025 for the "detection of rearrangements in two genes, using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms", BRAF and RET; the FDA summary adds that results "are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product". In the FDA summary, agreement was 100 per cent for RET (13 of 13 positive) and 92.3 per cent for BRAF (12 of 13). A Tempus study describes xR as "a whole-transcriptome RNA-seq assay" and, in 67,278 patients who had both RNA and DNA sequencing, found that adding RNA increased detection of driver gene fusions by 21 per cent over DNA alone (Gai 2025). The maker's page could not be read.
RNA from fixed tumour tissue is captured with a whole-exome probe set plus custom probes and sequenced; the FDA-cleared version reports rearrangements in BRAF and RET.
| Region | Year | Indication |
|---|---|---|
| US | 2025 | FDA 510(k) clearance (K241868) for detection of BRAF and RET rearrangements in RNA from solid tumour tissue |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Tempus xR" OR ABSTRACT:"Tempus xR" OR TITLE:"Tempus xR IVD" OR ABSTRACT:"Tempus xR IVD" OR TITLE:"xR IVD" OR ABSTRACT:"xR IVD") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Tempus xR, not a curated reading list.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares the tags test, rna.
Shares the tags test, rna.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/