New Publication Further Validates SeptiCyte® RAPID for Disease Severity Assessment and Triaging in COVID-19 Patients with Extensive Lung Injury

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Mar 02, 2023, 08:00 ET

SeptiCyte® RAPID accurately measured disease severity in COVID-19 patients, when compared to a CT-scan based reference method
SeptiScores™ were unaffected by anti-inflammatory treatments, consistent with SeptiCyte gene involvement in sepsis-related pathways other than the immediate-early response

SEATTLE and BRISBANE, Australia, March 2, 2023 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the publication of a study in the journal Viruses, validating the use of SeptiCyte® RAPID as a tool to measure disease severity in COVID-19 patients, in comparison to a reference method based on chest computed tomography (CT) imaging. The study, entitled "Stratification of COVID-19 severity using SeptiCyte RAPID, a novel host immune response test," was published on February 2, 2023, and is available online. The study indicates that SeptiCyte RAPID may have utility in place of or in addition to chest CT for identifying COVID-19 patients at risk of poor evolution.

The study was conducted at Foch Hospital in Suresnes, France. EDTA whole blood samples were collected from 67 patients during admission to the Emergency Department (ED), from 23 patients during admission to the Intensive Care Unit (ICU), and from 4 patients in conventional units. Investigators evaluated SeptiCyte® RAPID as a measure of disease severity and as a triaging tool for COVID-19 patients admitted to the ED and requiring hospitalization and potential ICU admission. Reference diagnoses of COVID-19 disease severity were based on the percentage of specific lung abnormalities or damage as observed by a radiologist on a chest CT scan.

SeptiCyte RAPID was able to differentiate severe + critical COVID-19 requiring admission to the ICU from mild + moderate COVID-19 cases (AUC 0.86). SeptiCyte RAPID also discriminated patients with lung injury above 50% on CT Scan (AUC = 0.88 for critical + severe vs. absence + mild + moderate + extensive) and could identify patients with extensive lung injury (25 – 50%) requiring ICU admission. During follow-up of the patients, the SeptiScore™ remained elevated in patients with lung injury above 50%, whereas other biological markers such as CRP decreased, likely due to anti-inflammatory treatments such as corticosteroids and tocilizumab received by patients. SeptiCyte RAPID thus could help to identify patients with severe forms of COVID-19 in the ED, as well as during follow-up.

"Emergency Medicine clinicians are in need of a rapid standardized risk assessment tool for the progression of COVID-19 disease severity that avoids extended wait times between patients' first presentation and clinical and imaging test results. To date, clinicians use a combination of chest imaging by X-ray or CT and biochemical tests to assess disease severity in patients with COVID-19. Hospitals often do not have 24-hour access to imaging or even the transportation infrastructure to move critically-ill patients to a larger facilities for this type of testing," commented Professor Marc Vasse, Chief of Service, Laboratory of Medical Biology at Foch Hospital and Principal Investigator of the study. "The results of this study indicate the potential clinical utility of SeptiCyte RAPID to be used as a COVID-19 disease severity indicator and risk stratification / triaging tool throughout a patient's health journey, and warrants further testing."

"Interventional COVID-19 treatments, including corticosteroids and tocilizumab, have the potential to modulate biochemical or hematological parameters, like CRP, to normal levels, as evidenced in this study. SeptiScores persisted at high levels throughout patients' trajectories and remained unaffected by anti-inflammatory treatments while CRP was negatively modulated in patients receiving these treatments. This is likely due to SeptiCyte RAPID uniquely measuring the PLAC8 and PLA2G7 genes that are not in the acute phase response pathway of the body's innate immune response," commented Roy Davis, Chief Medical Officer of Immunexpress.

"We are pleased to learn of an additional potential use case scenario for SeptiCyte RAPID to evaluate disease severity in COVID-19 patients with extensive lung injury from a simple EDTA blood draw. EDTA sample types are a universal feature of hematology testing, and expanding compatibility of our test with this sample type will enable our technology to be utilized by emergency medicine clinicians across multiple disciplines," said Rollie Carlson, PhD, CEO of Immunexpress. "Clinicians can perform the SeptiCyte RAPID assessment with an estimated two minutes of handling time with results in one hour, foregoing the difficulties of transporting critically ill patients throughout healthcare systems and awaiting other hematological and imaging test results that require extended wait times. We look forward to continuing to research the capabilities of SeptiCyte RAPID as a tool for emergency medicine clinicians and their patients."

About SeptiCyte® RAPID

SeptiCyte® RAPID is a sample-to-answer, cartridge-based, host response molecular test for sepsis using reverse transcription polymerase chain reaction (RT-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 runs on the.Biocartis Idylla™ Platform.

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, SeptiCyte® RAPID has been FDA cleared for use in hospitalized patients suspected of sepsis.

About Immunexpress

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 with the ease-of-use of the revolutionary 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 support 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.

For more information, visit http://www.septicyte.com and http://www.immunexpress.com/. Follow Immunexpress on Twitter and LinkedIn.

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SOURCE Immunexpress, Inc.