FDA Clearance – Clinical Validation
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 1,3
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
 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.
 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
- 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
- reports results based on the probability of a patient having sepsis
- SeptiCyte™ is being translated to near-patient testing technology with the aim of reducing the test turnaround time to less than 90 minutes and with hands-on-time of less than 5 minutes
- Clinicians will then be able to access better diagnostic information for patients suspected of sepsis within a clinically actionable timeframe
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