prnewswireJuly 12, 2021
Tag: Immunexpress , COVID-19 , ECCMID
Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced a late-breaking presentation, titled "Use of SeptiCyte RAPID to assess the risk of ICU admission in COVID-19 patients" (ID#4984), demonstrating the performance of SeptiCyte® RAPID in triaging COVID-19 patients at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), taking place virtually from July 9-12, 2021.
SeptiCyte® RAPID host immune response assay uses peripheral blood gene expression biomarkers to provide a probability of sepsis in patients presenting with clinical signs of systemic inflammation. Immunexpress evaluated the performance of SeptiCyte® RAPID using patient samples from COVID-19 positive cases as part of a retrospective cohort, collected by collaborators at Hospital del Mar, Barcelona, Spain. Patients were stratified into critical, severe, moderate and mild categories, based on their COVID-19 disease clinical characteristics. The test result, SeptiScore®, is reported as a value of 0 to 15 in three interpretation bands which represent an increase in the risk of sepsis. Test results obtained directly from blood samples are available within approximately 1 hour.
Diagnostic performance demonstrated that SeptiCyte® RAPID discriminated critical/severe COVID-19 cases from moderate/mild cases. For patients admitted to the ICU that required an escalation in care, SeptiCyte® RAPID had 85% specificity in samples with SeptiScore results falling in band 3. Additionally, SeptiCyte® RAPID outperformed a commonly used clinical lab test for COVID-19 patient management, IL-6, with a p-value of ≤ 0.05.
"The COVID-19 pandemic revealed the continued need for clinicians to have access to technologies that efficiently discriminate patients with mild infection from those that have an elevated risk for serious complications, including viral or secondary bacterial sepsis," said Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress. "The data presented demonstrate the performance of SeptiCyte® RAPID to discriminate severe and critical cases from mild and moderate COVID-19 cases, which correlated with the need for ICU level care. Utilization of SeptiCyte® RAPID has the potential to equip clinicians with tools for early sepsis diagnosis and to help ensure timely initiation of sepsis management protocols, which can save patients' lives."
Roy Davis, M.D., Ph.D., MHA, Chief Medical Officer of Immunexpress, added, "Delayed treatment of sepsis can increase risk of death for the affected patient. This robust data set, of over 100 patients, demonstrated that a high SeptiScore in patients initially admitted to the hospital correlated with the need for subsequent transfer to the ICU. The SeptiScore® provided a statistically and clinically accurate prediction of the risk of critical or severe COVID-19 disease. More accurate tests such as this, used in conjunction with current diagnostic tools, are essential and these results indicate the potential for SeptiCyte® RAPID to aid physicians in clinical decision making for severe COVID-19 patients upon hospital admission."
The virtual presentation can be accessed during the congress by registered attendees. The submitted abstract and a poster of the study are also accessible through the Academy section of the company's product website at www.septicyte.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 commercialization partnership with Biocartis in Europe.
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