Pharmaceuticals company Roche (SIX:RO) (OTCQX:RHHBY) disclosed on Friday that it has passed US Food and Drug Administration (FDA) clearance for the expanded use of its Elecsys B·R·A·H·M·S PCT assay to aid in antibiotic therapy decision making in patients with sepsis, lower respiratory tract infections (LRTIs), acute exacerbations of chronic obstructive pulmonary disease (aeCOPD), community acquired pneumonia (CAP) as well as acute bronchitis.

Previously, the Elecsys B·R·A·H·M·S PCT was cleared by the US FDA to evaluate the risk of progression to severe sepsis and septic shock in critically ill patients and 28-day mortality after diagnosis, according to the company.

The company's 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 provide important insights into a patient's response to antibiotics, which helps clinicians determine when to change or stop treatment.

In conjunction, the company's 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.