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


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.


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]

[2] 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

[3] 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). 

[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


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.


Journal of Clinical Medicine logo

Validation of SeptiCyte RAPID to Discriminate Sepsis from Non-Infectious Systemic Inflammation

Chart prepared by Cone Health. User-readable PDF version is linked, below.

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


A commercial rapid host-response test in COVID-19 severity stratification and triage


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


Use of SeptiCyte® RAPID Assay to Assess the Risk of ICU admission in COVID-19 Patients

SCCM 2021

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


In Silico Performance of a Rapid Sepsis Test in Patients with Candidemia

BMC Medicine_Blue 01_RGB

Blood transcriptomic discrimination of bacterial and viral infections in the emergency department: a multi-cohort observational validation study


A pilot study of a novel molecular host response assay to diagnose infection in patients after high-risk gastro-intestinal surgery


The effect of uncertainty in patient classification on diagnostic performance estimations