Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay. The update allows the assay to run without a matched normal specimen (blood or saliva) when not viable, expanding practical use in real-world oncology workflows. Tempus also said the approval enables migration of its solid tumor DNA portfolio into pricing under Advanced Diagnostic Laboratory Test structures. Separately, Cepheid’s point-of-care molecular vaginitis assay showed a large shift in diagnostic and treatment accuracy in a UPMC Magee-Womens Hospital clinical study. In the trial, correctly treated patients at the first visit rose from about 52% under standard methods to nearly 90% with the 60-minute in-office molecular panel.
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