The FDA cleared Diasorin’s customizable multiplex gastrointestinal pathogen PCR panel, expanding the Liaison Plex Flex menu with a 24-pathogen assay that labs can narrow or broaden using Flex software. The clearance also adds specific organisms not commonly covered by competing panels, including Microsporidia, Dientamoeba fragilis, and Strongyloides stercoralis. In separate action, the FDA approved AstraZeneca’s baxdrostat (Baxfendy), a first-in-class aldosterone synthase inhibitor for hypertension in combination with other antihypertensive medications in patients not adequately controlled. Regulators’ rationale was tied to outcomes from the BaxHTN phase III program, with data supporting both primary and secondary endpoints. Together, the moves highlight a push toward (1) syndromic diagnostics with higher customization and stewardship controls and (2) novel antihypertensive mechanisms beyond established drug classes.
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