FDA approval for a tumor-only next-generation sequencing approach for solid tumors marks a practical shift in how comprehensive genomic profiling can be deployed in routine care. Tempus AI said the U.S. Food and Drug Administration approved a tumor-only indication for its xT CDx assay, allowing testing when matched normal tissue is not viable or unavailable. Tempus xT CDx is a 648-gene tissue-based panel that detects substitutions and indels and also assesses microsatellite instability status from tumor-only material. Previously, matched normal samples were typically required for comprehensive genomic profiling; the expanded indication aims to widen access to molecular stratification in earlier treatment decisions. The company also said the approval enables migration of its solid tumor DNA portfolio to a unified Advanced Diagnostic Laboratory Test pricing structure, targeting an average selling price benefit starting in 2027. The change could streamline payer and reimbursement dynamics for companion-style genomic testing across more clinical workflows.