SeptiCyte®
Technology

The Immune System Holds the Key

SeptiCyte® technology can assess a patient’s immune response by quantifying and analyzing gene expression signatures from whole blood, providing actionable results in about an hour to guide the physician in optimizing patient management decisions.

The immune system holds the key to unlocking a better understanding, diagnosis and treatment of patients suspected of sepsis. The human immune system responds specifically to an invading pathogen and produces an abundant genetic signal that is reliably detected by SeptiCyte® technology. Using mathematical algorithms, a patient’s genetic material from the septic immune response is rapidly analyzed providing actionable clinical information in suspected sepsis cases.

Earlier, Faster and More Reliable Than Identification of Pathogens.

By testing whole blood directly, the assay is able to detect the response of the patient’s immune system to an infection earlier, faster and more accurately than methods that rely on identifying pathogens. SeptiCyte® host response results allow clinicians to better interpret positive and negative pathogen results, empowering them to swiftly differentiate systemic inflammatory response syndrome (SIRS) from sepsis in critically ill patients to be admitted to the ICU.

Clinical research results published in peer-reviewed medical journals have demonstrated the accuracy of SeptiCyte® technology in both adults and children suspected of sepsis.

Email us for more information on the benefits of the SeptiCyte® RAPID technology.

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Bibliography

CLINICAL PUBLICATIONS

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

REVIEW PUBLICATIONS

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”

IN SILICO Analyses

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.

POSTERS

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”

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”

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”

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”

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”

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

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