Roche has announced that it has received clearance from the U.S. 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.
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 18-minute assay is designed to measure procalcitonin (PCT) levels in the blood. Elevated PCT levels in a patient indicate a likely bacterial infection, while low PCT levels in a patient who has symptoms of infection may indicate the cause to be viral or non-infectious in nature. The kinetics of PCT also provide important insights into a patient’s response to antibiotics, which helps clinicians determine when to change or stop treatment. Elecsys B·R·A·H·M·S PCT assay may be added to any of the cobas® immunoassay instruments, offering access to critical insights in low-, mid- and high-volume laboratories.
Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation said, “There is a global health crisis caused by the emergence and proliferation of resistant bacteria. 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.”
Mathias Egermark, MD, Vice President and International Business Leader, Cardiac and Critical Care, Roche Diagnostics International said, “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.”