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

[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] 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
  • 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

For more information visit Partnership with Biocartis.

Biocartis’ sample-to-result Idylla™ platform



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


Profile of the SeptiCyte™ LAB gene expression assay to diagnose infection in critically ill patients.


Modeling Improved Patient Management and Hospital Savings with SeptiCyte™ LAB in the Diagnosis of Sepsis at ICU Admission


Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU