Profile of the SeptiCyte™ LAB gene expression assay to diagnose infection in critically ill patients

D M Verboom, M E Koster-Brouwer, Mrj Varkila, Mjm Bonten, O L Cremer

Research output: Contribution to journalReview articlepeer-review


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 by the FDA in the United States to distinguish infectious from non-infectious causes of systemic inflammation in critically ill patients. The test consists of the simultaneous amplification of four RNA transcripts (CEACAM4, LAMP1, PLAC8, and PLA2G7) in whole blood using a quantitative real time PCR reaction. This review provides an overview of the challenges in the diagnosis of sepsis, the development of gene expression signatures, and a detailed description of available clinical performance studies evaluating SeptiCyte™ LAB.

Original languageEnglish
Pages (from-to)95-108
Number of pages14
JournalExpert Review of Molecular Diagnostics
Issue number2
Early online date9 Jan 2019
Publication statusPublished - Feb 2019


  • SeptiCyte™ LAB
  • biomarkers
  • diagnosis
  • gene expression assay
  • infection
  • sepsis
  • Humans
  • Transcriptome
  • Critical Illness
  • Gene Expression Profiling/instrumentation
  • Sepsis/diagnosis
  • SeptiCyte (TM) LAB


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