Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay. The tissue-based 648-gene test can be used for comprehensive genomic profiling in solid tumors and functions as a companion diagnostic for colorectal cancer patients who may benefit from Eli Lilly’s Erbitux and Amgen’s Vectibix. Previously, xT CDx required a matched normal specimen; the new label allows the assay to run as tumor-only when matched blood or saliva is not available or viable. Tempus said the approval supports a shift toward running across its portfolio under pricing aligned with Advanced Diagnostic Laboratory Test frameworks. The company estimated an average selling price benefit of $200 starting in 2027, framing the regulatory change as both clinical flexibility and reimbursement strategy support.