Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, allowing comprehensive genomic profiling to be run when matched normal (blood or saliva) is unavailable. The assay covers 648 genes and includes microsatellite instability assessment using tumor-only material—an operational change aimed at widening access for real-world specimens. Tempus said the expanded label enables migration of its solid-tumor DNA portfolio to FDA-approved Advanced Diagnostic Laboratory Test pricing and forecasted an average selling price benefit of $200 starting in 2027. The decision also positions Tempus as the first lab to hold companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling.