Four-Biomarker Signature Differentiates Viral and Non-Viral Causes of Systemic Inflammation

SEATTLE, June 6, 2017 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostic company with the first FDA cleared host response assay for suspected sepsis patients, today announced the publication, in Scientific Reports, of data demonstrating the ability of a four-biomarker blood signature to discriminate viral and non-viral causes of systemic inflammation in a variety of clinical settings. The manuscript, which is available online, describes the investigation to determine if a blood-based signature could be discovered and show a host systemic response to viral infection.ⁱ

Systemic Inflammation (SI) typically presents itself with non-descript clinical signs such as fever and increased respiratory and heart rates, and can be due to a variety of underlying non-infectious or infectious causes including trauma, thermal burns, surgery, ischemia-reperfusion events, and viral or bacterial infections. Establishing the underlying cause of systemic inflammation can be difficult and therefore poses diagnosis, treatment and management challenges for clinicians.^{ii iii iv v vi}

"While current diagnostic methods have improved the capacity to differentiate causes of SI, limitations still exist and point to the need for alternative approaches," said Richard Brandon, PhD, chief scientific officer of Immunexpress. "Our investigation of biomarker studies indicates that the four-gene signature may aid clinicians in differentiating systemic inflammation due to viral infection, which in critically ill patients may require immediate treatment and initiation of appropriate management procedures."

The analysis, based on 44 public datasets and two Immunexpress clinical studies in adults and children, identified and validated a four-gene expression signature which includes the Interferon Stimulated Gene (15) (ISG15), Interleukin 16 (IL16), 2'5'-Oligoadenylate Synthetase Like (OASL), and Adhesion G Protein Coupled Receptor E5 (ADGRE5). In each of 13 validation datasets involving humans and other mammals, and all seven Baltimore virus classification groups, the signature demonstrated a meaningful (p <0.05) distinction between viral and non-viral causes.^vii

About Immunexpress

Immunexpress is a Seattle-based molecular diagnostic company committed to improving outcomes for patients suspected of sepsis. Immunexpress's SeptiCyte™ technology rapidly quantifies, directly from whole blood, specific molecular markers from the patient's own immune system – the "host response". SeptiCyte™ LAB, recently cleared by the FDA, is the first of its kind in using the host immune system to differentiate systemic inflammatory response syndrome (SIRS) and sepsis. Detecting the host's response to infection has the potential to differentiate infection earlier, faster and more accurately than finding the invading pathogen because it is independent of whether or not the pathogen is present in the sample. Immunexpress's pipeline includes several assays for readily available instruments, including random access, point-of-care (POC) and sample-to-answer.

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ⁱ Samson, D.L., et. al. A Four-Biomarker Blood Signature Discriminates Systemic Inflammation Due to Viral Infection Versus Other Etiologies.  Sci Rep. 2017 June 6. Doi: 10.1038/s41598-017-02325-8

ⁱⁱ Comstedt, P., Storgaard, M. & Lassen, A. T. The Systemic Inflammatory Response Syndrome (SIRS) in acutely hospitalised medical patients: a cohort study. Scand. J. Trauma Resusc. Emerg. Med. 17, 67–72 (2009).

ⁱⁱⁱ Pavare, J., Grope, I. & Gardovska, D. Prevalence of systemic inflammatory response syndrome (SIRS) in hospitalized children: a point prevalence study. BMC Pediatr. 9, 25–30 (2009).

^iv Munro, N. Fever in acute and critical care: a diagnostic approach. AACN Adv. Crit. Care 25, 237–248 (2014).

^v Niska, R., Bhuiya, F. & Xu, J. National hospital ambulatory medical care survey: 2007 emergency department summary. Natl. Health Stat. Report 26, 1–31 (2010).

^vi Braykov, N. P., et al. Assessment of empirical antibiotic therapy optimisation in six hospitals: an observational cohort study. The Lancet Infectious Diseases 14, 1220–1227 (2014).

^vii Samson, D.L., et. al. A Four-Biomarker Blood Signature Discriminates Systemic Inflammation Due to Viral Infection Versus Other Etiologies.  Sci Rep. 2017 June 6. Doi: 10.1038/s41598-017-02325-8.

SOURCE Immunexpress, Inc.

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