Tempus AI said the FDA approved a tumor-only indication for its xT CDx 648-gene next-generation sequencing platform, expanding flexibility when matched normal tissue is unavailable. The assay is intended as a comprehensive genomic profiling tool and serves as a companion diagnostic for patient selection for targeted therapies, including Eli Lilly’s Erbitux and Amgen’s Vectibix. The tumor-only update allows the test to determine microsatellite instability status based on tumor-only genomic signatures and removes the requirement for matched samples such as blood or saliva when not viable. Tempus also said the approval supports a strategy to move its solid tumor DNA portfolio under unified Advanced Diagnostic Laboratory Test pricing. For diagnostics developers, the approval is a step toward simplifying workflows and potentially improving access by reducing sample constraints for real-world oncology testing.