“This exploratory case study of longitudinal SeptiScores® in a case of severe malaria demonstrates:
1) SeptiScore®ʼs potential as a correlate of severity in parasitic infections (in addition to bacterial and viral sepsis)
2) SeptiScore®ʼs potential as an indicator of treatment response in such infections.”
Presented at ASTMH, November 13-17, New Orleans. https://www.astmh.org
Prospective Evaluation Of The Septicyte® Rapid Assay For The Identification Of Systemic Infectious Diseases In Patients With Suspected Sepsis
“In this real-life evaluation on a German ICU, SeptiScores were higher in patients with sepsis-like clinical symptomatologies and detectable microbiological pathogens than in controls.”
Sophia Benthien, Cem Ucarer, Vitalie Mazuru, Institute of Medical Microbiology and Hygiene, Saarland University, Homburg, Germany; Carsten Zeiner, Guy Danziger, Philipp M. Lepper, Department of Internal Medicine V, Pneumology and Intensive Care Medicine, Saarland University, Homburg, Germany; Sören L. Becker, Institute of Medical Microbiology and Hygiene, Saarland University, Homburg, Germany
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2024
Septicyte RAPID, A New Biomarker For The Diagnosis Of Nosocomial Infections In ICU Polytrauma Patients
“SeptiCyte RAPID appears to be a promising diagnostic tool to complement ICU physician assessment of nosocomial infection likelihood, especially VAP, in ICU polytrauma patients.”
L. Neutre, M. Bouras, M. Denis, C. Douarec, T. Goronflot, A. Roquilly
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2024
Accurate Sepsis Identification Using Septicyte Rapid And Other Biomarkers Of Systemic Inflammation
“No combination of biomarkers outperformed SeptiScore® alone, or models including SeptiScore®, at identifying sepsis.”
Dr. Roy F. Davis, MD, Ph.D., Dr. Tom van der Poll, MD, Dr. Robert Balk, MD, Dr. Richard Brandon, BVSc (Hons) Ph.D., Dr. Silvia Cermelli Ph.D., Dr. Krupa Navalkar, Ph.D
Research Snapshot Theater: Sepsis, Adult I at The Society of Critical Care Medicine’s (SCCM) 2024 Critical Care Congress.
Critical Care Medicine | volume 52, Issue 1: p S684, January 2024.|DOI: 10.1097/01.ccm.0001003860.47668.ec
Performance of SeptiCyte Rapid for determining probability of sepsis in immunocompromised patients or those on immunosuppressant therapy
“SeptiCyte® RAPID is reliable for the determination of probability of sepsis in immunocompromised patients, or for patients on immunotherapy, and across a broad range of white cell counts.”
Krupa Navalkar, PhD, Tom van der Poll, MD, PhD, Robert Balk, MD, Richard Brandon, BVSc (Hons) PhD, MBA, Roy Davis, MD, PhD, MHA
Association for Molecular Pathology, Annual Meeting Abstracts | Volume 25, Issue 11, Supplement, S1-S186 | Association for Molecular Pathology (AMP) 2023 Annual Meeting Abstracts, 14 -18 Nov. 2023
Potential Impact Of A Host Response Gene Expression Sepsis Assay (Septicyte Rapid) In A Tertiary Emergency Department Setting
“Sepsis diagnostic and initiation of treatment decisions should include probability of sepsis with SeptiCyte RAPID being an additional aid.”
Sadia Aslam, MD, Rakesh Alva, MD, and Erkan Hassan of PharmD
Original Investigation Posters at CHEST 2023
Critical Care| Volume 164, Issue 4, Supplement, A1608, October 2023, DOI: https://doi.org/10.1016/j.chest.2023.07.1105
Immunexpress and University Hospitals Cleveland Medical Center Present Quality Improvement Feasibility with SeptiCyte® RAPID
American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo 2023
“The early accurate diagnosis of sepsis can be challenging, but recent advancements in FDA-cleared lab tests have introduced new tools that may enhance earlier diagnosis.”
Layla Sankari, Hallie H Dolin, Rana Hejal, Habib I Mohammad, Anne Windau, Christina Greig, Deepali R Savadekar, Casey M Weisenberger, Kenneth Remy, Frank Jacono, and Xiaochun S Zhang. University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH
Use of NEWS2 and SeptiCyte® RAPID in Acutely Ill Patients Suspected of Sepsis
“A combination of SeptiCyte RAPID with NEWS2 may assist clinicians in rapidly and accurately identifying and assessing risk of poor outcomes in acutely ill patients with Sepsis.”
Dr. Richard Brandon, Dr. Krupa A. Navalkar, Dr. Thomas D. Yager, Dr. Silvia Cermelli, Dr. Roy F. Davis; International Symposium on Intensive Care & Emergency Medicine (ISICEM) 2023, March 21-24, 2023
Clarifying Uncertainty In Sepsis Diagnosis Using A Gene Expression Assay
“For patients initially classified as indeterminate and then reassessed by a forced diagnosis, SeptiCyte® RAPID significantly differentiated between SIRS and sepsis.”
E. Hassan, P. Meijer, R. Davis, S. Cermelli and R. Balk
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2023
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
International Symposium on Intensive Care & Emergency Medicine (ISICEM) 2023, March 21-24, 2023
Brussels Congress Center, Brussels
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 (AMP) 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.”
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022
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
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2021
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”
International Symposium on Intensive Care and Emergency Medicine (ISICEM) 2016 on Mar. 15, 2016, in Brussels, Belgium
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.
