Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced further SeptiCyte® RAPID data demonstrating performance, reproducibility and identification of fungal infections, in two poster presentations at the Association for Molecular Pathology (AMP) 2020 Annual Meeting & Expo on Nov. 16-20.
“Our SeptiCyte® technology leverages host-response gene-expression biomarkers to determine the probability of sepsis,” said Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress. “The data presented at AMP 2020 continues to strengthen our clinical validation of SeptiCyte® RAPID which is based upon the predicate FDA cleared SeptiCyte® LAB product. We also demonstrate that SeptiCyte® RAPID can identify fungal infections, reinforcing the test’s utility to identify sepsis that includes bacterial, fungal, or viral pathogens.”
The first poster titled, “Comparison of a cartridge-based host gene expression test to a manual method for use in the diagnosis of sepsis,” compares SeptiCyte® RAPID with our 510(k) FDA cleared SeptiCyte® LAB, as well as inter-operator performance of SeptiCyte® RAPID cartridges. SeptiCyte® RAPID combines SeptiCyte® technology with the Biocartis Idylla™ platform* to differentiate infection positive (sepsis) from infection negative systemic inflammation in patients suspected of sepsis. SeptiCyte® RAPID results are reported as a SeptiScore® between 0 and 15, with higher scores representing higher probability of sepsis. Testing was conducted at two clinical laboratories, Intermountain Healthcare Central Lab and Providence Oregon Regional Laboratory, and SeptiScore® results generated by SeptiCyte® RAPID were compared to SeptiCyte LAB scores from the initial clinical trial for FDA clearance. Results demonstrate that SeptiCyte® RAPID run on the Biocartis Idylla™ platform correlate strongly with SeptiCyte® LAB and are reproducible for 28 clinical samples (r2=0.97 and r2=0.98). Reproducibility for inter-operator performance of SeptiCyte® RAPID cartridges on different Idylla™ machines located at three different laboratories was 0.994. Studies are ongoing for further validation of the performance of SeptiCyte® at multiple locations throughout the U.S. These initial results demonstrate that SeptiCyte® RAPID, which has a turn-around time of ~1 hour, is a robust and reproducible sepsis test with potential for near-patient testing.
Margret D. Oethinger, M.D., Ph.D., Medical Director at Providence Oregon Regional Laboratory said, “SeptiCyte® RAPID, as a host response test, appears to address some of the current challenges of sepsis diagnosis and our technologists found it very easy to run and interpret the test results.”
A second poster titled, “In Silico Performance of a Rapid Sepsis Test in Patients with Candidemia,” highlights SeptiCyte® RAPID performance in distinguishing patients with candidemia from clinical controls with the SeptiCyte® RAPID signature. Immunexpress has previously demonstrated that SeptiCyte® RAPID gene expression biomarkers can differentiate both bacterial and viral sepsis from infection negative systemic inflammation. Here, using in silico data from an Affymetrix U219 microarray, the two fungal biomarkers had Area Under the Curves (AUCs) of 1.00, 0.942 and 0.942 for differentiating candidemia (n=6), from healthy patients (n=42), from patients who were initially suspected of sepsis and treated with antibiotics but subsequently demonstrated not to have an infection (n=26) and from infection negative systemic inflammation patients (n=43). This in silico data demonstrates that SeptiCyte® RAPID can distinguish Candidemia and complements prior data demonstrating that SeptiCyte® RAPID can also differentiate viral and bacterial sepsis.
“Candida infections present a significant clinical challenge, as such a diagnostic for fungal sepsis when blood cultures are negative would enable early targeted therapy and thereby likely improve patient outcomes, so this initial in silico data is encouraging,” said Tom van der Poll, M.D., Ph.D., Professor of Medicine and Chair of the Department of Medicine in the Amsterdam UMC, University of Amsterdam, the Netherlands.
The e-posters and accompanying presentations can be found on the AMP Meeting website and are also accessible through Events page on the Newsroom section of Immunexpress’ website at www.immunexpress.com.
Immunexpress is a molecular diagnostic company, based out of Seattle, 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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