Roche PCT Assay Cleared for Expanded Use

Roche announced that it has received clearance from the US Food and Drug Administration (FDA) for the expanded use of its Elecsys B·R·A·H·M·S PCT assay to aid in antibiotic therapy decision making. “There is a global health crisis caused by the emergence and proliferation of resistant bacteria,” said Dr Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. “With this assay’s expanded claims, clinicians now have an important tool in the battle against antibiotic resistance and are better equipped to provide patients the right treatment, for the right period of time.” The Elecsys B·R·A·H·M·S 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. “This is an important step in the global struggle against antibiotic resistance. The quality and legacy of Roche Diagnostics’ Elecsys B·R·A·H·M·S PCT will enable doctors to feel more confident in their decisions when managing these patients,” said Mathias Egermark, MD, Vice President and International Business Leader, Cardiac and Critical Care, Roche Diagnostics International. – Medical Buyer Bureau