Publications

Background The performance of a new diagnostic test is typically evaluated against a comparator which is assumed to correspond closely to some true state of interest. Judgments about the new test’s performance are based on the differences between the outputs of the test and comparator. It is commonly assumed that a small amount of uncertainty…

Sepsis is a severe and frequently occurring clinical syndrome, caused by the inflammatory response to infections. Recent studies on the human transcriptome during sepsis have yielded several gene-expression assays that might assist physicians during clinical assessment of patients suspected of sepsis. SeptiCyte™ LAB (Immunexpress, Seattle, WA) is the first gene expression assay that was cleared…

Background: The ability to accurately diagnose sepsis at ICU admission is key to effective clinical management, patient safety, and efficient hospital resource utilization. Most tests used for sepsis diagnosis, including pathogen detection and host-based biomarker approaches, are lacking in either sensitivity or specificity, resulting in a clinical assumption of sepsis, patient overtreatment with antimicrobials, and…

Miller et al., American Journal of Respiratory and Critical Care Medicine | SeptiCyte LAB appears to be a promising diagnostic tool to complement physician assessment of infection likelihood in critically ill adult patients with systemic inflammation.

Sampson et al., Scientific Reports | Data demonstrates the ability of a four-biomarker blood signature to discriminate viral and non-viral causes of systemic inflammation in a variety of clinical settings. Discussed is the investigation of how to determine if a blood-based signature could be discovered and show a host systemic response to viral infection.

Zimmerman et al., Critical Care Medicine | SeptiCyte Lab is able to discriminate clearly between clinically well-defined and homogeneous postcardiopulmonary bypass and clinically overt severe sepsis syndrome groups in children. A broader investigation among children with more heterogeneous inflammation-associated diagnoses and care settings is warranted.

McHugh et al., PLOS Medicine | SeptiCyte Lab is a rapid molecular assay that may be clinically useful in managing ICU patients with systemic inflammation. Further study in population-based cohorts is needed to validate this assay for clinical use.

Sutherland et al., Critical Care | A novel molecular biomarker test based on a panel of 42-gene expression markers has demonstrated a clinically relevant sensitivity and specificity profile, and has the capacity for early detection of sepsis via the monitoring of critical care patients.