Tempus AI secured FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay, expanding how the 648-gene platform can be used for molecular profiling of solid tumors. The assay is intended to also serve as a companion diagnostic for identifying colorectal cancer patients who may benefit from Eli Lilly’s Erbitux and Amgen’s Vectibix. Previously, the test required patient-matched normal samples; the new label allows running without a matched normal when blood or saliva specimens are not viable. Tempus said it is the first lab to hold companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling. The change is also positioned as a reimbursement and portfolio migration step, with Tempus projecting an average selling price benefit of $200 starting in 2027 as it moves more of its DNA solid tumor assays under Advanced Diagnostic Laboratory Test pricing.