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FDA Clears Siemens Healthineers BRAHMS PCT Assay

NEW YORK (360Dx) – Siemens Healthineers has received US Food and Drug Administration clearance for the Atellica IM BRAHMS PCT Assay for sepsis assessment, assigning mortality risk, and antibiotic therapy decision-making in the emergency department and intensive care unit.

Michael Reitermann, president of the diagnostics segment, Siemens Healthineers, announced the clearance during a presentation this week at the 70th American Association for Clinical Chemistry Scientific Meeting & Clinical Lab Expo in Chicago.

Procalcitonin is a sensitive and specific biomarker that can be used to help determine if a patient has a bacterial infection that may progress to sepsis. The biomarker can be used to gauge the severity of the infection and the response to antibiotic therapy. The Atellica assay's capability to assist with antibiotic therapy decisions can help address the rising problem of antibiotic resistance, Siemens said.

Sepsis is the body’s overwhelming response to infection, which can lead to tissue damage, organ failure, amputations, and even death if not diagnosed and treated early.