Profile of the SeptiCyte™ LAB gene expression assay to diagnose infection in critically ill patients
Verboom, D M; Koster-Brouwer, M E; Varkila, Mrj; Bonten, Mjm; Cremer, O L
(2019) Expert Review of Molecular Diagnostics, volume 19, issue 2, pp. 95 - 108
(Article)
Abstract
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
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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.
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Keywords: SeptiCyte™ LAB, biomarkers, diagnosis, gene expression assay, infection, sepsis, Humans, Transcriptome, Critical Illness, Gene Expression Profiling/instrumentation, Sepsis/diagnosis, SeptiCyte (TM) LAB, Genetics, Molecular Medicine, Molecular Biology, Pathology and Forensic Medicine, Journal Article, Review, Research Support, Non-U.S. Gov't
ISSN: 1473-7159
Publisher: Expert Reviews Ltd.
Note: Funding Information: DM Verboom: Innovative Medicine Initiative (IMI), European Union’s Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ in-kind contribution (COMBACTE-CARE, grant agreement 115 620). Funding Information: D. Verboom and M. Bonten were funded by the Innovative Medicine Initiative (IMI), European Union’s Seventh Framework Programme [FP7/ 2007–2013]; EFPIA companies’ in-kind contribution [COMBACTE-CARE, grant agreement 115 620]. Funding Information: MJM Bonten: Innovative Medicine Initiative (IMI), European Union’s Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ in-kind contribution (COMBACTE-CARE, grant agreement 115 620). Funding Information: The UMC Utrecht received a grant from CTMM (project MARS, grant 04I-201) in which Immunexpress was included as a providing party and received funding from Immunexpress for further research. Except for a factual accuracy check, there was no scientific involvement by Immunexpress in preparing this review. Publisher Copyright: © 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.
(Peer reviewed)