June 9, 2026—The FDA has granted approval for a tumor-only indication for Tempus AI’s xT CDx next-generation sequencing platform. Tempus xT CDx is a 648-gene, tissue-based assay intended for molecular profiling of all solid tumor malignancies. It also serves as a companion diagnostic to identify colorectal cancer patients who may benefit from targeted therapies, specifically Erbitux (cetuximab) and Vectibix (panitumumab).
This approval allows the test to run as a tumor-only assay when a matched normal specimen (blood or saliva) is not viable or available, and it paves the way for Tempus to migrate its DNA solid tumor portfolio to FDA-approved assays priced under its current advanced diagnostic laboratory test pricing.
xT CDx is a qualitative NGS-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants and multinucleotide variants) and insertion and deletion alterations in 648 genes in patients with previously diagnosed solid malignant neoplasms. The assay uses DNA isolated from formalin-fixed, paraffin embedded tumor tissue specimens and, when available, patient-matched blood or saliva specimens. The device also detects microsatellite instability status based on a genomic signature from the tumor specimen only.