SEATTLE, Sept. 23, 2020 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today new data in collaboration with researchers at the University College of London. The publication in BMC Medicine describes the identification and validation of a new blood transcriptomic signature, SeptiCyte TRIAGE, for detection of the host response to bacterial infection,.1 SeptiCyte® TRIAGE was discovered by computational machine learning on public datasets, followed by validation in a prospective observational cohort of Emergency Department (ED) patients.
Combining SeptiCyte® TRIAGE with a previously identified signature for the host response to viral infection, SeptiCyte® VIRUS2, enables discrimination between bacterial and viral infections in Emergency Department patients.
"The combination of SeptiCyte® TRIAGE and SeptiCyte® VIRUS could potentially be used as the first screening test in the Emergency Department for patients presenting with fever in the absence of microbiology test results," said Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress. "This research demonstrates the utility of Immunexpress' biomarker discovery capabilities, our strong developmental pipeline, and the continued advancement of our existing technology."
Discovery and validation of SeptiCyte® VIRUS has been previously described in an earlier publication.2 SeptiCyte® TRIAGE was discovered and validated specifically to rule out bacterial infection in ED patients, and to be used in combination with SeptiCyte® VIRUS. The article demonstrates SeptiCyte® TRIAGE signature validation in independent case-control data from over 1500 samples, and in combination with SeptiCyte® VIRUS using pooled data from a further 1088 samples. An observational validation study tested the performance of these signatures on whole blood from prospectively collected ED patients with fever. The combination of SeptiCyte® TRIAGE with SeptiCyte® VIRUS discriminated bacterial and viral infections in febrile ED patients with an area under the receiver operating characteristic curve (AUC) of 0.95, compared to 0.79 for peripheral blood leukocyte counts (WCC) and 0.73 for C-reactive protein (CRP). SeptiCyte® TRIAGE and SeptiCyte® VIRUS testing on a prospectively collected ED cohort of 332 patients showed that 69% had bacterial infections (of which 45% were microbiologically proven), and 30% had viral infections (of which 16.5% had laboratory confirmation).
"We have demonstrated that a newly identified blood transcriptomic signature, SeptiCyte® TRIAGE, can be used in combination with SeptiCyte® VIRUS, without prior knowledge of a patients infection status, to differentiate bacterial and viral infections," said Mahdad Noursadeghi, Ph.D., of the University College London. "This combination of molecular signatures offers a potentially transformative approach to guide early antibiotic prescribing decisions, direct targeted microbiological testing and to support infection control practice in patients with suspected bacterial and viral infections."
Immunexpress is a molecular diagnostic company, founded in Australia and based out of Seattle, Washington, U.S., committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte® technology can assess a patient's dysregulated immune response by quantifying and analyzing gene expression from whole blood, providing actionable results in about an hour to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID is a lab test for sepsis that combines SeptiCyte® technology with the Biocartis' Idylla™ platform*, empowering clinicians to swiftly differentiate infection positive (sepsis) from infection negative systemic inflammation in patients suspected of sepsis; diagnosing bacterial sepsis, viral sepsis, or fungal infections. This powerful combination of technologies enhances certainty for early sepsis diagnosis, to improve clinical outcomes and lower healthcare costs.
In March 2020, Immunexpress received CE Marking of SeptiCyte® RAPID and announced a long-term commercialization partnership with Biocartis in Europe.
*Immunexpress is licensed to use the Idylla™ trademark from Biocartis NV.
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1 Sampson, D., Yager, T.D., Fox, B. et al. Blood transcriptomic discrimination of bacterial and viral infections in the emergency department: a multi-cohort observational validation study. BMC Med 18, 185 (2020). https://doi.org/10.1186/s12916-020-01653-3
2 Sampson, D.L., Fox, B.A., Yager, T.D. et al. A Four-Biomarker Blood Signature Discriminates Systemic Inflammation Due to Viral Infection Versus Other Etiologies. Sci Rep 7, 2914 (2017). https://doi.org/10.1038/s41598-017-02325-8
SOURCE Immunexpress, Inc.