Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay. The authorization expands Tempus’ 648-gene solid tumor platform so it can be used without a matched normal sample when blood or saliva is not viable. xT CDx is intended to provide comprehensive genomic profiling across solid tumors and also operates as a companion diagnostic to identify colorectal cancer patients who may benefit from Eli Lilly’s Erbitux and Amgen’s Vectibix. The new authorization supports microsatellite instability assessment based on tumor tissue signatures, using DNA from formalin-fixed paraffin-embedded specimens. Tempus said the tumor-only flexibility improves workflow options for clinical scenarios where matched samples are difficult to obtain, while also setting up migration of its broader DNA solid tumor portfolio into FDA-approved pricing under Advanced Diagnostic Laboratory Test rules. The approval is likely to matter for diagnostics operations at oncology centers and community practices, where specimen logistics can be a key bottleneck for molecular testing adoption.