FDAnews Device Daily Bulletin

SeptiCyte LAB Device Discerns Sepsis from Infection-Negative Systemic Inflammation in Critically Ill Children

Sept. 26, 2016

Immunexpress has published data demonstrating the ability of SeptiCyte LAB to distinguish sepsis from infection-negative systemic inflammation in the pediatric intensive care population.

SeptiCyte LAB evaluated blood samples from children with clinical severe sepsis syndrome (CSSS), as compared to an infection-negative systemic inflammation subpopulation, children immediately post-cardiopulmonary bypass surgery (PCPB). The device was shown to have high accuracy for discriminating critically ill children with CSSS versus children recovering from PCPB.

Sepsis is one of the most common causes of childhood deaths, and treatment for sepsis one of the largest unmet clinical needs. — Cynthia Jessup

View today's stories