SeptiCyte®Lab is a rapid molecular assay that measures a patient’s gene expression level to differentiate between sepsis and infection-negative systemic inflammation.
The manuscript describes the identification of a classifier to accurately discriminate sepsis patients from patients with non-septic inflammation and the conversion of the classifier to RT-qPCR format which is the basis of the SeptiCyte® technology. The study details the validation of the technology across five independent patient cohorts and demonstrates clinical performance that outperforms clinical parameters including procalcitonin.
“Current technologies for the diagnosis of sepsis that seek to identify the causative pathogen are slow and frequently result in false negatives,” said Roslyn Brandon, President and CEO of Immunexpress. “Our technology, described today in PLOS Medicine, examines the host-response and can provide a probability of sepsis in 100% of cases just a few hours after a physician’s initial suspicion of sepsis. We look forward to sharing data from our prospective FDA regulatory trials of SeptiCyte® next year.”