Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, expanding how clinicians can profile solid tumors with comprehensive genomic profiling. The test is intended for 648-gene profiling and also enables microsatellite instability assessment based on tumor-only genomic signatures. The expanded indication allows use when a matched normal specimen, such as blood or saliva, is not viable or available, after the platform previously required matched normal material. Tempus said it is positioned to migrate its DNA solid tumor portfolio under its Advanced Diagnostic Laboratory Test pricing framework. This kind of labeling expansion can reduce barriers to molecular testing in real-world clinical settings, where paired specimens are often delayed or not obtainable.