Roche PCT assay cleared for expanded use - Important tool in antibiotic resistance crisis

Elecsys® B·R·A·H·M·S PCT™ (procalcitonin) helps clinicians assess presence and severity of certain bacterial infections and patient response to antibiotics

INDIANAPOLIS/PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.

"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.

About the Elecsys B·R·A·H·M·S PCT assay

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.

For further information, please contact:

Christina Vysma

Roche Diagnostics Corporation

Indianapolis, Indiana USA


Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.


Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.