About SeptiCyte®
The SeptiCyte® technology rapidly quantifies specific biomarkers to aid clinicians in the early identification
of infection in suspected sepsis patients.
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 finding the pathogen.
To learn more about SeptiCyte® RAPID, visit https://septicyte.com/
Immunexpress hosted a Tapas & Technology reception which included a presentation about the challenges of sepsis diagnosis and Immunexpress’ approach of using the host immune response to diagnose sepsis, SeptiCyte®. Speakers included Dr. Steven P. LaRosa, M.D. of Beth Israel Lahey Health and Dr. Russell R. Miller III, MD, MPH, FCCM of FirstHealth of the Carolinas.
About SeptiCyte® RAPID
In January 2018, Immunexpress entered into a partnership with Biocartis to develop and commercialize Immunexpress’ SeptiCyte® test for use on the Biocartis’ sample-to-result Idylla™ platform. The collaboration produced SeptiCyte® RAPID, the fully-automated, rapid near-patient host response test that quickly provides accurate clinical information for the diagnosis of sepsis.
In March 2020, SeptiCyte® RAPID received CE Mark and is currently distributed in Europe by Biocartis.
In March 2021, Immunexpress and Abacus Dx signed a distributor agreement for SeptiCyte® RAPID, which is available for IVD use in New Zealand and RUO use in Australia.
In November 2021, SeptiCyte® RAPID received FDA clearance following expansive clinical testing and comparative studies, representing the first one-hour, direct-from-blood sepsis test.
To learn more about SeptiCyte® RAPID, visit https://septicyte.com/
In sepsis diagnosis, every minute counts!
Clinicians are working against the clock when treating sepsis. Our goal is to transform sepsis diagnostics by providing clinicians with the technology to rapidly enable and confidently make the right treatment decisions.
In January 2018, we announced a partnership with Biocartis to develop and commercialize a fully automated SeptiCyte® LAB test for use on the Biocartis’ sample-to-answer real-time PCR Idylla™ platform.
Revolutionize sepsis detection. Fast. Easy. Reliable.
This is a unique, real time PCR (Polymerase Chain Reaction) system offering highly-reliable
molecular information in virtually any lab setting.
2 minutes handling time. About 60 minutes for results.
The combination of Immunexpress’ SeptiCyte® technology with Biocartis’ Idylla™ platform empowers physicians to swiftly differentiate sepsis from SIRS in critically ill patients.
SeptiCyte® technology uses proprietary biomarker signatures to assess the response of a patient’s immune system to infections to provide clinically meaningful data for optimized treatment. By leveraging the rapid turn-around time of the Idylla™ platform, outcomes are improved and costs reduced.
For each hour delay in diagnosis, the chance of death increases by 8%.1 In one large multi-site study measuring the economic impact of delays in sepsis diagnosis, the average cost per patient linked to a delay in diagnosis was in excess of $20K.2
Immunexpress and Biocartis developed the SeptiCyte® RAPID test onto the Idylla™ platform, allowing results to be generated in a one-hour timeframe to support the time-critical decision-making required in the management of sepsis patients.
To learn more about SeptiCyte® RAPID, visit https://septicyte.com/
[1] Kumar, Anand, et al. "Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock." Critical care medicine 34.6 (2006): 1589-1596.
[2] Paoli, Carly J., et al. "Epidemiology and Costs of Sepsis in the United States-An Analysis Based on Timing of Diagnosis and Severity Level." Critical care medicine (2018).
Understanding Host Response to create better diagnostic tools
Determining infection status in suspected sepsis patients has traditionally focused
on finding and characterizing the invading pathogen.
Detection of an invading pathogen is often slow with no identification in the majority of suspected sepsis cases. However, the immune system responds specifically to an invading pathogen and produces an abundant genetic signal that is reliably detected by SeptiCyte® technology.
Specific Host Response
How to improve accuracy and accessibility to rapid clinical test results?
Do not focus only on identifying the pathogen.
The immune system holds the key to unlocking better understanding, diagnosis and treatment
of patients suspected of sepsis by using the specific host response.
Immune cells contain large amounts of RNA – a measurable genetic material that is a snapshot of the immune conversation.
Our algorithmic approach quantifies the patient’s septic immune response and rapidly reports actionable clinical information in 100% of suspected sepsis cases.
Immunexpress’ SeptiCyte® RAPID test is the only on-market FDA cleared test for the management of sepsis using the patient’s immune response to infection. Multi-national clinical trials have shown SeptiCyte® to be the single most accurate test for the diagnosis of sepsis.
Accuracy and Accessibility
Minimize the chance of false negative and false positive results by combining data
from a host response assay WITH pathogen information.
SeptiCyte® host response results allow clinicians to better interpret positive and negative pathogen results.
Benefits of Early, Accurate Diagnosis
Source information on epidemiology of sepsis: World Sepsis Day
Patented Biomarkers
Immunexpress has granted patents and applications in key markets that cover sepsis diagnostic technology
measuring the host immune response.
Claims include biomarkers, algorithms, analysis methods, treatments, compositions and kits.
These patents include combinations of biomarkers for differentiating sepsis and SIRS, diagnosing bacterial, viral,
herpes and protozoal infections, and differentiating pathogenic bacteria.
About SeptiCyte® LAB
Immunexpress’ pipeline includes several assays for readily available instruments,
including random access, point-of-care (POC) and sample-to-answer.
SeptiCyte® LAB received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation
in critically ill patients on their first day of ICU admission.
Find out more here.