References

Performance of a Molecular Host Response Assay in Patients Suspected of Sepsis and Stratified by qSOFA

1. In this study, a large percentage of patients initially suspected of sepsis were retrospectively determined to not have sepsis.
2. SeptiCyte® RAPID used alone outperformed other rapid and easily measured markers of sepsis.
3. SeptiCyte® RAPID should be used early in the diagnostic pathway for patients suspected of sepsis to determine likelihood of sepsis. qSOFA, should be used to determine likelihood of poor outcome once a sepsis likelihood has been determined.
4. Rapid and early identification of patients with sepsis using SeptiCyte® RAPID can lead to better management of patients suspected of sepsis.

Dr. Silvia Cermelli, Dr. Krupa A. Navalkar, Dr. Roy F. Davis, Dr. Richard Brandon, Dr. Thomas D. Yager, Dr. Robert Balk

Multi-Site Validation of EDTA Blood As A Sample Type For SeptiCyte® RAPID CE-IVD, A Near Patient Diagnostic Test For Sepsis On The Biocartis Idylla System

“The results of this study confirm the equivalence of PAXgene® and EDTA blood sample types in the clinical setting when processed with the SeptiCyte® RAPID CE-IVD cartridge. Combined with the small 240 µL blood volume requirement and the convenient and long storage conditions, the addition of the widely used EDTA blood tube as a validated sample type has the potential to greatly expand the clinical utility of this new near patient sepsis diagnostic”

Parcina M, Vasse M, Hannet I, Kirk J. Multi-site validation of EDTA blood as a sample type for SeptiCyte® RAPID CE-IVD, a near-patient diagnostic test for sepsis on the Biocartis Idylla™ System. Association for Molecular Pathology 2022 Annual Meeting Abstracts. J Mol Diagn 2022, 24:S1 Abstract G001

Clinical Validation of Septicyte Rapid, An FDA Cleared Gene Expression Assay for Sepsis

“SeptiCyte® RAPID has been shown to out perform other tools for suspected sepsis including lactate and PCT, providing an earlier and more accurate sepsis diagnosis. This fast and accurate sepsis diagnosis improves patient outcomes.”

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

“SeptiCyte® RAPID can be processed using EDTA blood samples. The assay can distinguish COVID-19 cases with Severe or Critical presentation on CT from those with Mild or Moderate presentation.”

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 proved superior to routinely used diagnostic tools for the differentiation of sepsis from infection negative systemic inflammation”

Hassan E, Davis R, Sampson D, et al. Open Forum Infectious Diseases, Volume 8, Issue Supplement_1, November 2021, S588.

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

“Diagnostic performance demonstrated that SeptiCyte® RAPID discriminated critical/severe COVID-19 cases from moderate/mild cases.”

M Hardy-Werbin et al ESMID e-library

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

“A study showing the performance of SeptiCyte RAPID in patients with malignancies and/or on anti-neoplastic or corticosteroid therapies”

Davis R, Navalkar K, van der Poll T, et al. Critical Care Medicine 2021;49(1):643

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

“SeptiCyte® RAPID test is a rapid, repeatable, reproducible, near-patient, immune-response sepsis diagnostic, providing accurate results in ~ 1 hr to differentiate sepsis from SIRS”

Cermelli S, Heath K, Kauleers I. et al. The Journal of Molecular Diagnostics 2020;22(11)S26.

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

“SeptiCyte® RAPID differentiated patients with candidemia from those with INSI/SIRS, not infected and healthy subjects”

Sampson D, Bulter J, Sengers H. The Journal of Molecular Diagnostics 2020;22(11)S29

Clinical Performance of a Rapid Sepsis Test on a Near-Patient Molecular Testing Platform

“First demonstration of a validated, fully-integrated, rapid, repeatable, reproducible, near-patient, immune-response sepsis diagnostic”

“Preliminary diagnostic characteristics of SeptiCyte^® RAPID test in differentiating sepsis from SIRS”

J Kirk et al Critical Care 2020 24 (Suppl 1): 87

Accuracy of Septicyte^® for Diagnosis of Sepsis Across a Broad Range of Patients

“The SeptiCyte^® signature has broad diagnostic utility in heterogenous sepsis patient population”

K Navaler et al Critical Care 2020 24 (Suppl 1): 87

Analysis of Discordance Between the Clinical Impressions of Patients with Systemic Inflammation: Results of a Prospective Non-Interventional Trial (Venus A)

“First quantification of uncertainty in sepsis diagnosis at admission, discharge and over the patient stay in a matched cohort”

Validation of a Host Response Assay, Septicyte^® Lab, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU

“FDA-clearance study of the first gene signature assay for sepsis”

Sepsis Or SIRS? Actionable Results in About an Hour

“SeptiCyte^® technology provides actionable results to aid early recognition and treatment of sepsis patients, independently of the presence of the causative pathogen”

MTEC

Sensitive and Specific Diagnosis of Sepsis in Critically Ill Children Utilizing Host Gene Expression

“Pilot validation of the SeptiCyte^® technology among critically ill children”

Zimmerman J, Sullivan E, Sampson D, et al. Critical Care Medicine 2015;43(12):258.

Stratification of COVID-19 Severity Using SeptiCyte RAPID, A Novel Host Immune Response Test

SeptiCyte RAPID can be a useful tool to identify patients with severe forms of COVID-19 in ED, as well as during follow-up.

Evaluation of the host immune response assay SeptiCyte Rapid for potential triage of COVID-19 patients

The aim of this study was to evaluate SeptiCyte RAPID, a host immune response assay as a triaging tool for COVID-19 patients requiring hospitalization and potentially ICU care.

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

An article describing the research work that led to the validation and FDA market clearance of SeptiCyte LAB for differentiating sepsis from non-infectious systemic inflammation and the recent transition to SeptiCyte RAPID for a more rapid turnaround time on a near-patient platform

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

Clinical validation of a new approach using host response not pathogen detection to differentiate sepsis from SIRS

A Pilot Study of a Novel Molecular Host Response Assay to Diagnose Infection in Patients After High-Risk Gastro-Intestinal Surgery

A pilot study using host response, Septicyte^® LAB, to monitor patients post-surgery for the development of infectious complications

Diagnostic Accuracy of a Host Gene Expression Signature that Discriminates Clinical Severe Sepsis Syndrome and Infection-Negative Systemic Inflammation Among Critically Ill Children

Septicyte^® LAB, a test measuring host response, clearly differentiates sepsis from post-surgical inflammation in children

Validation of a Novel Molecular Host Response Assay to Diagnose Infection in Hospitalized Patients Admitted to the ICU with Acute Respiratory Failure

Validation of SeptiCyte^® LAB for use in ICU patients with acute respiratory failure

Emerging Technologies for Molecular Diagnosis of Sepsis

“SeptiCyte^® is a promising, novel, broad-based diagnostic test for sepsis.”

“Combining SeptiCyte^® with pathogen- and resistance-targeted tests that work within the same critical time frame could generate significant synergy.”

Towards Precision Medicine in Sepsis: a Position Paper from the European Society of Clinical Microbiology and Infectious Diseases

SeptiCyte^® LAB accurately described as “the first rapid molecular assay approved by the FDA to aid the intensive care physician as a diagnostic tool for differentiating sepsis and SIRS.”

To include SeptiCyte^® LAB. Biomarkers and Molecular Diagnostics for Early Detection and Targeted Management of Sepsis and Septic Shock in the Emergency Department.

“The most promising recent advance in host response-based platforms for sepsis diagnosis (in the ED) rely on omics-based methods.”

Profile of the SeptiCyte^® LAB Gene ExpressionAssay to Diagnose Infection in Critically Ill Patients

“Due to its high sensitivity, SeptiCyte^® LAB shows promise as a test to rule-out infectious causes of systemic inflammation in patients clinically presenting with sepsis-like symptoms.”

Biomarkers in Sepsis

“This rapid molecular assay is the first RNA-based clinical diagnostic tool derived from whole blood approved as a diagnostic test in critically ill patients”

Biomarkers and Molecular Diagnostics for Early Detection and Targeted Management of Sepsis and Septic Shock in the Emergency Department

“the 4 gene…RNAbased classifier SeptiCyte LAB was able to reliably discriminate sepsis from SIRS with an area under the receiver-operator characteristics curve of 0.82-0.89”

A Molecular Host Response Assay to Discriminate Between Sepsis and Infection-Negative Systemic Inflammation in Critically Ill Patients: Discovery and Validation in Independent Cohorts

Discovery and validation of the SeptiCyte^® LAB signature in critically ill patients demonstrating an AUC of 0.95 in unambiguous cases (definite sepsis) and controls (SIRS).

Validation of Diagnostic Gene Sets to Identify Critically Ill Patients with Sepsis

In silico analyses of SeptiCyte^® LAB genes for differentiating septic vs non-septic in 61 ventilated, critically ill patients over time. A single-site study.

Molecular Biomarker to Assist in Diagnosing Abdominal Sepsis upon ICU Admission

In silico analyses demonstrating AUC of 0.89 for SeptiCyte^® LAB for differentiating abdominal sepsis from abdominal post-surgical inflammation.

An Immune-cell Signature of Bacterial Sepsis

Validation of the biomarkers of SeptiCyte^® LAB or bacterial sepsis using single cell sequencing.