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

Expert Rev Mol Diagn. 2019 Feb;19(2):95-108. doi: 10.1080/14737159.2019.1567333. Epub 2019 Feb 5.


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.

Keywords: SeptiCyte™ LAB; biomarkers; diagnosis; gene expression assay; infection; sepsis.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Critical Illness
  • Gene Expression Profiling / instrumentation*
  • Gene Expression Profiling / methods*
  • Humans
  • Sepsis* / diagnosis
  • Sepsis* / genetics
  • Sepsis* / metabolism
  • Transcriptome*