Roche Pharma Approves Test to Aid Sepsis Diagnosis in Newborns

The Elecsys IL-6 immunoassay from Roche has become the first IL-6 test to receive a recognized claim for use in the diagnosis of newborn sepsis in countries accepting the CE Mark. Elecsys IL-6 assists clinicians in battling the effects of newborn sepsis by allowing for early detection. Early and improved diagnosis can help with antibiotic adherence, thereby lowering mortality rates and minimizing long-term effects of sepsis, as per Pharmabiz.

"Sepsis is one of the leading causes of death in newborns, and we need to do everything we can to prevent these deaths," said Matt Sause, CEO of Roche Diagnostics. "The first approval for the use of IL-6 with newborns is a significant step forward in assisting clinicians in confidently diagnosing neonatal sepsis earlier and saving lives." Neonatal sepsis is a bloodstream infection that occurs within the first four weeks of life and has a significant morbidity and fatality rate. Neonatal sepsis can begin with mild symptoms but quickly escalate to multisystem organ failure.

To avoid serious and life-threatening consequences, early detection and immediate action are critical. Testing for IL-6 is appropriate for the early detection of newborn sepsis because it rises rapidly in response to infection, much sooner than other markers, making it a stronger early warning marker of inflammation, infection, or sepsis. Clinicians can make earlier and more suitable interventions to provide neonates the best chance of a positive outcome with earlier diagnosis. The Elecsys IL-6 can help with this, and the exam only takes 18 minutes to run while only utilizing a minimal amount of blood.