FDA Clearance – Clinical Validation
NEPTUNE – Near Patient Molecular Testing in Sepsis
Prospective, multicenter observational study to evaluate the real-time performance of SeptiCyte®RAPID in critically ill adults. Data from this cohort were combined to results of archived samples from previous clinical studies (NTC01905033 and NCT02127502) to establish the overall performance of SeptiCyte® RAPID to distinguish between sepsis and noninfectious systemic inflammation and to support FDA clearance for SeptiCyte® RAPID.
- Keck Memorial Hospital at University of Southern California and Los Angeles County+USC Medical Center, Los Angeles, CA
- Rush University Medical Center, Chicago, IL
- Emory at Grady Memorial Hospital, Atlanta, GA
SeptiCyte® RAPID is a near-patient testing technology, with a test turnaround time to approximately one hour and with hands-on-time of less than 5 minutes.
SeptiCyte® RAPID strongly discriminate sepsis and infection-negative systemic inflammation providing clinicians access to better diagnostic information for patients suspected of sepsis and within a clinically actionable timeframe.
VENUS – The Validation of septic gene expression using SeptiCyte®
(Clinicaltrials.gov identifier: NCT02127502)
Prospective, multicenter observational study demonstrating the diagnostic performance of SeptiCyte® LAB to distinguish between sepsis and noninfectious systemic inflammation in critically ill adults.
This pivotal trial was the basis for FDA clearance for SeptiCyte® LAB.
In a study cohort of ~450 patients representing both US and European populations, SeptiCyte® LAB:
- discriminated patients with either SIRS or sepsis better than other currently available tests or clinical parameters (ROC AUC of 0.86)1,2
- identified 100% of sepsis patients with a positive blood culture
- SeptiScore™ was the single best measurement for the diagnosis of sepsis, as judged by a blinded independent panel of expert physicians
- performance was correlated to the degree of clinical diagnostic certainty in the gold standard, supporting the hypothesis that the diagnostic accuracy of SeptiCyte® LAB surpasses that of the gold standard in key patient populations 1,4
For additional information about design and results of clinical trials for SeptiCyte® LAB that led to its FDA clearance please refer to the publication by Miller et al.1
 Miller, Russell M III, et al. "Validation of a Host Response Assay, Septicyte™ LAB, for Discriminating Sepsis from SIRS in the ICU." Am J Respir Crit Care Med. (2018) Apr 6. [Epub ahead of print]
 Zimmerman, Jerry J., et al. "Diagnostic accuracy of a host gene expression signature that discriminates clinical severe sepsis syndrome and infection-negative systemic inflammation among critically ill children." Critical Care Medicine 45.4 (2017): e418-e425.
 Verboom, Diana M, et al. "A pilot study of a novel molecular host response assay to diagnose infection in patients after high-risk gastro-intestinal surgery" Journal of Critical Care 54.83-87 (2019).
 Klouwenberg, Peter MC Klein, et al. "Interobserver agreement of Centers for Disease Control and Prevention criteria for classifying infections in critically ill patients." Critical Care Medicine 41.10 (2013): 2373-2378.
Enrollment included 447 patients with suspected sepsis between 2014-2016
- Intermountain Medical Center, Murray, UT
- Latter Day Saints Hospital, Salt Lake City, UT
- Johns Hopkins Hospital, Baltimore, MD
- Rush University Medical Center, Chicago, IL
- Loyola University Medical Center, Maywood, IL
- Northwell Healthcare, Long Island, NY
- Grady Memorial Hospital, Atlanta, GA
- Academic Medical Center in Amsterdam, NL
SeptiCyte® LAB is the first host-response gene-expression assay cleared by the FDA as an aid for diagnosis of sepsis (K163260), is specific for whether a patient has an infection and does not correlate to disease severity, uses a patient blood sample to measure the specific response of four genes to infection is currently in laboratory kit form with a turnaround time of ~6 hours, and reports results based on the probability of a patient having sepsis.
Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU
A Four-Biomarker Blood Signature Discriminates Systemic Inflammation Due to Viral Infection Versus Other Etiologies
Diagnostic Accuracy of a Host Gene Expression Signature That Discriminates Clinical Severe Sepsis Syndrome and Infection-Negative Systemic Inflammation Among Critically Ill Children
A Molecular Host Response Assay to Discriminate Between Sepsis and Infection-Negative Systemic Inflammation in Critically Ill Patients: Discovery and Validation in Independent Cohorts
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