Two diagnostics moves signaled regulatory and reimbursement progress for real-world adoption. Personalis’ NeXT Personal minimal residual disease assay won expanded Medicare coverage via MolDX for immunotherapy monitoring across late-stage solid tumors, supported by evidence in collaboration with Spain’s Vall d’Hebron Institute of Oncology. In Europe, Cepheid received CE marking under the IVDR for its multiplex PCR Xpert GI Panel, enabling detection of 11 gastrointestinal pathogens from a single stool sample with results in about 74 minutes on GeneXpert systems. Together, the updates point to accelerating pathway toward reimbursement and broader clinical workflow integration for molecular diagnostics across oncology monitoring and infectious disease testing.
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