FDA approves expanding indication of the Elecsys BRAHMS PCT assay to aid antibiotic treatment in infection.- Roche.
Roche announced that it has received clearance from the FDA for the expanded use of its Elecsys BRAHMS PCT assay to aid in antibiotic therapy decision making. The Elecsys BRAHMS PCT was previously cleared by the FDA to evaluate the risk of progression to severe sepsis and septic shock in critically ill patients and 28-day mortality after diagnosis.
The assay may now be used to support antibiotic treatment decisions in patients with suspected or confirmed sepsis and suspected or confirmed lower respiratory tract infections (LRTIs), defined as acute exacerbations of chronic obstructive pulmonary disease (aeCOPD), community acquired pneumonia (CAP), and acute bronchitis.
Comment: The Elecsys BRAHMS PCT assay is designed to provide full automation, which means no reagent preparation or hands-on testing is required. This assay offers same-day testing capability with an incubation time of only 18 minutes.
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