FDA Clearance – Clinical Validation
NEPTUNE – 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.
Clinical Sites
- 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
Summary
SeptiCyte® RAPID is a 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.
Results
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
[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]
[4] 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.
Clinical Sites
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
Summary
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.
Publications

Chart: Potential impact of a host response gene expression sepsis assay (septicyte rapid) in a tertiary emergency department setting

Comparison of Lactate, Procalcitonin and a Gene Signature Assay Alone or in Combination to Differentiate Sepsis from Infection Negative Systemic Inflammation in ICU Patients

SeptiCyte® RAPID in Sepsis Cases with Malignancies or Treated with Anitneoplastics/Immunosuppressants

A Fully Integrated Diagnostic Test to Discriminate Sepsis from Infection-Negative Systemic Inflammation

Comparison of a Cartridge-Based Host Gene Expressions Test to a Manual Method for Use in the Diagnosis of Sepsis
