Roche secured FDA 510(k) clearance, a CLIA waiver and CE marking for a Cobas Liat point-of-care PCR test that identifies Bordetella pertussis, parapertussis and holmesii in 15 minutes. The company said rapid differentiation of Bordetella species will enable faster clinical decisions and infection-control measures, particularly in settings with vulnerable patients. The Cobas Liat assay runs on Roche’s established point-of-care platform and returns a specific species-level readout, which Roche says can reduce empiric treatment and improve antimicrobial stewardship. The company also noted the test’s utility in distinguishing emergent B. holmesii from classic pertussis. Regulatory clearance plus CLIA waiver positions the assay for wide use in urgent-care and hospital settings and may shift testing paradigms for pertussis-like illnesses.
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