Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing platform, expanding how clinicians can use the 648-gene tissue assay. Previously, the test required a matched normal sample; under the new indication, it can run without matched blood or saliva when those specimens are not viable. The approval also enables Tempus to migrate its solid-tumor DNA portfolio to FDA-priced Advanced Diagnostic Laboratory Test reimbursement categories, which the company said could improve average selling price starting in 2027. This change reduces operational barriers for molecular profiling in community settings where matched normals are frequently missing.