Tempus AI won FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform. The assay is positioned for comprehensive genomic profiling of solid tumors and acts as a companion diagnostic to identify colorectal cancer patients who may benefit from targeted therapies including Eli Lilly’s Erbitux (cetuximab) and Amgen’s Vectibix (panitumumab). The expanded indication allows the test to run without a matched normal sample when blood or saliva specimens are not viable, addressing a common operational barrier in molecular testing workflows. Tempus said the company is also preparing to unify broader portions of its solid-tumor DNA portfolio under FDA-approved pricing. The approval could improve turnaround and coverage for oncology centers that struggle to collect matched specimens, while reinforcing Tempus’ footprint in FDA-cleared diagnostics.