SEATTLE and BRISBANE, Australia, Feb. 2, 2023. Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the publication of a study in Scientific Reports, a journal in the Nature portfolio, validating the use of SeptiCyte RAPID as a triaging tool for COVID-19 patients requiring hospitalization and potentially ICU care. The study, entitled “Evaluation of the host immune response assay SeptiCyte RAPID for potential triage of COVID-19 patients,” was published on January 18th and is available online.
The study was conducted at Hospital del Mar in Barcelona, a university hospital in Spain recognized as a pioneering center for health care, training and research. Samples were collected within 48 hours of intake from 146 patients who were hospitalized during July to December 2020 with proven SARS-CoV-2 infection and clinical signs of COVID-19 disease. Investigators evaluated SeptiCyte RAPID as a tool for determining COVID-19 severity and predicting the need for ICU admission. Retrospective clinical assessment was used as a comparator by classifying patients as having critical, severe, moderate, or mild COVID-19 under WHO guidelines.
SeptiCyte RAPID was able to stratify COVID-19 cases according to these severity guidelines, with a discrimination power that was significantly better (by AUC or p-value) than conventional laboratory tests including CRP, lactate, creatine, IL-6, and D-dimer. Importantly, SeptiCyte RAPID, when drawn within 48 hours of intake, correctly discriminated critical or severe patients requiring later ICU admission from mild patients who did not need ICU care, with AUC and p values of 0.93 (p<0.0001) and 0.85 (p=0.0003) respectively. In a broader comparison, critical + severe patients who required later ICU care were compared to mild + moderate patients not requiring ICU care, with an AUC of 0.79 (p = 0.0001).
“Since COVID-19 has the potential to advance quickly and cause dangerously low blood oxygen levels that require intensive care measures, the ability to appropriately and promptly triage patients is of the utmost importance. Due to the significant impact of COVID-19 cases on healthcare systems, tools like SeptiCyte RAPID, which can deliver results in less than an hour with little user engagement, may speed the triaging process and enhance patient outcomes,” said Dr. Juan P. Horcajada, MD, PhD, Head of the Department of Infectious Diseases at Hospital del Mar, Parc de Salut MAR, in Barcelona, Spain, and co-principal investigator of the study alongside co-principal investigator Dr. Beatriz Bellosillo, Ph.D, Head of Molecular Biology in the Pathology Department at Hospital del Mar.
“Given the recent reported commonalities in pathology and progression between COVID-19 and sepsis, we wanted to assess whether a sepsis stratification diagnostic tool like SeptiCyte RAPID could be useful to COVID-19 patients,” said Dr. Roy Davis, CMO Immunexpress. “We were pleased to discover that SeptiCyte RAPID performed significantly better than routinely used single-biomarker assays for assessing COVID-19 severity. The study suggests that elevated SeptiScore values may potentially serve as indicators to increase patient monitoring and to identify patients at risk of ICU admission.”
“Hospitals are in need of a rapid and accurate assessment of infectious disease severity for patient outcome and optimal intensive care capacity management. With an infection-based disease like COVID-19 that has the potential to impede lung function and lower blood oxygen levels to dangerous levels at a startling rate, it is essential that patients are accurately triaged and monitored upon hospital intake. These data, along with SeptiCyte RAPID’s well validated clinical capacity for differentiating sepsis from non-infectious systemic inflammation host response syndromes, suggest that SeptiCyte RAPID may give emergency rooms a powerful tool to assess COVID-19 severity within one hour of obtaining a patient’s blood sample,” added Rollie Carlson, PhD, CEO of Immunexpress.
About SeptiCyte RAPID
SeptiCyteRAPID is a sample-to-answer, cartridge-based, host response molecular test for sepsis using reverse transcription polymerase chain reaction (PCR) which quantifies the relative expression levels of host response genes isolated from whole blood. SeptiCyte RAPID is used in conjunction with clinical assessments, vital signs and laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation response syndromes in patients with organ dysfunction and high infection risk. SeptiCyte RAPID generates a score (SeptiScore) that falls within four discrete Interpretation Bands based on the increasing likelihood of sepsis. SeptiCyte RAPID is intended for in-vitro diagnostic use and is used on the Biocartis Idylla™ System.
SeptiCyte RAPID is CE Marked as a near-patient sample-to-answer test in European Union (EU) member countries and those harmonized with the EU IVD Directive (98/79/EC). As of November 2021, SeptiCyteRAPID has been FDA cleared for use in hospitalized patients suspected of sepsis.
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 as fast as about an hour from sepsis suspicion, 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; it supports differentiating infection (bacterial, viral, fungal) positive (sepsis) from infection negative systemic inflammation in patients with organ dysfunction and high risk infectious exposures. This powerful test enhances early sepsis detection and can strongly supports its diagnosis in the crucial first hour(s) that determines clinical outcome. SeptiCyte RAPID also has a high potential to reduce sepsis associated healthcare costs.
In March 2020, Immunexpress received CE marking of SeptiCyte RAPID and announced a commercialization partnership with Biocartis in Europe. In November 2021, Immunexpress received FDA clearance for SeptiCyte RAPID.
SOURCE Immunexpress, Inc.
Posted: February 2023