SeptiCyte RAPID : Sepsis detection technology that can triage COVID-19 patients

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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.

Ian Bolland caught up with Dr. Rolland Carlson, CEO of Immunexpress, to talk about a molecular diagnostic, SeptiCyte RAPID, which is used to detect sepsis and offers the potential to triage severe COVID-19 patients in the emergency department.

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.

Finding and characterizing the 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.

Using mathematical algorithms, patient’s genetic material from the septic immune response is rapidly analyzed providing actionable clinical information in 100% of suspected sepsis cases.

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Immunexpress’ SeptiCyte® LAB is the only FDA cleared test for the management of sepsis using the patient’s genomic 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

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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.

About SeptiCyte® RAPID

In January 2018, Immunexpress entered into an agreement with Biocartis to develop and commercialize Immunexpress’ SeptiCyte® test for use on Biocartis’ sample-to-result Idylla™ platform. The collaboration promises a fully-automated, rapid near-patient host response test that quickly provides accurate life-saving clinical information.

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.

Idylla System with 3 instruments

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.https://player.vimeo.com/video/286230197

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

Molecular testing procedure traditional vs Idylla

Under the partnership, Immunexpress and Biocartis will codevelop the SeptiCyte® test onto the Idylla platform, allowing results to be generated in a timeframe that supports the time-critical decision-making
required in the management of sepsis patients.

Briefly, tell us more about Immunexpress – how did the idea to start the company come about?

Immunexpress was the result of compelling proof-of-concept research in animal models. Our researchers, who were veterinarians, were focused on studying an induced endotoxemia model, which is a sepsis-like condition. The team performed time-course analyses of peripheral blood gene expression as the animals developed endotoxemia and saw profound differential gene expression. From these initial studies, and due to the similar disease profiles, we believed that a gene expression signature could be identified in humans for differentiating sepsis from non-infectious systemic inflammation.

In addition to these initial promising scientific results, there is a massive unmet need for an improved approach to sepsis diagnostics in humans and there is a large potential market. Over 1.7 million Americans develop sepsis each year and an even larger number are suspected of sepsis. Therefore, the idea to start Immunexpress came from a solution meeting a market need.

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.

Can you tell us more about SeptiCyte RAPID? Why is the rapid diagnosis of sepsis so important?

SeptiCyte RAPID is a blood-based gene signature assay that can discriminate sepsis from non-infectious systemic inflammation with a high negative predictive value or high positive predictive value. Our test results indicate if there is a high probability that a suspected sepsis patient does (high positive prediction) or does not (high negative predication) have sepsis. The test uses an easily accessible whole blood sample where circulating leukocytes act as reporters for the immune status of the rest of the body, providing detailed information on a patient’s immune status. The test gives healthcare providers results in about an hour. This can expedite clinical decision making and has the potential to improve patient outcomes.

With every hour delay in diagnosing severe sepsis there is an 8% increased risk of mortality, so an accurate, early, rapid test to rule in or rule out sepsis fulfills a critical unmet need for early identification and appropriate intervention for this life-threatening condition.

How was this test developed?

SeptiCyte RAPID biomarkers were discovered using complex bioinformatic analyses of peripheral blood gene expression of a large number of patients that we were confident had either non-infectious systemic inflammation or sepsis. The biomarkers were then validated using other datasets and patient populations to ensure good diagnostic performance including specificity and high positive and negative predictive value. The test has been validated in two formats, as a kit called SeptiCyte LAB which is FDA cleared, and as a cartridge called SeptiCyte RAPID.

How does the test measure immune response?

SeptiCyte RAPID is based on the measurement of the RNA quantity of genes found in peripheral blood leukocytes. As a person’s immune system responds to infection, some genes are up-regulated (increased gene expression leads to increased cellular RNA levels) and some are down-regulated. SeptiCyte RAPID measures the up-regulated genes and the down-regulated genes using Reverse Transcription-quantitative Polymerase Chain Reaction also known as RT-qPCR. A ratio of these RT-qPCR measurements provides a SeptiScore which is a number between 0 and 15. The higher the SeptiScore the higher the probability that a patient has sepsis.

It seems like the test has seen a lot of development as we’ve come to know more about COVID-19, can you talk about that further?

SeptiCyte RAPID can differentiate systemic inflammation from bacterial, viral, and fungal sepsis. Even before the COVID-19 pandemic, we had demonstrated that SeptiCyte RAPID differentiated patients with systemic inflammation from those with sepsis caused by many different types of viruses, including influenza, respiratory syncytial virus, dengue and Ebola. There is strong literature support that severe COVID-19 is in fact viral sepsis. We believe SeptiCyte RAPID may be used to diagnose sepsis in severe COVID-19 cases, and that it can be used to differentiate between mild/moderate and severe COVID-19.

Can this kind of testing be done at scale and quickly?

One of the key benefits of SeptiCyte RAPID is that the test has a fast turnaround time of one hour. It is run on the Idylla platform, a fully automated real-time PCR system made by Immunexpress’ partner Biocartis NV. Biocartis currently has over 1,300 Idylla instruments installed throughout the world. Although the sample is run one sample per cartridge on the Idylla platform, it can be scaled up to run as many as eight cartridges at a time on a random-access basis. The platform has a small footprint which can be used in remote locations and requires minimal lab technician expertise. The platform is easy to operate with less than five minutes of technician hands-on-time required to set up a test.

How is the test manufactured?

SeptiCyte RAPID is manufactured in a single-use cartridge format. The manufacturing process is highly specialised because the cartridge is fully self-contained, fully automated, sealed and disposable. The cartridge contains all reagents necessary for sample extraction, PCR amplification followed by readout of quantitative test results determined by the Idylla instrument. Manufacturing is performed under rigorous quality assurance and release protocols to ensure reliability. The cartridge, which runs on the Biocartis NV Idylla platform, is QR coded to provide test-specific information and results tailored for Immunexpress SeptiCyte RAPID.

What steps are needed for the commercialisation of SeptiCyte RAPID globally? What is your supply chain and commercial strategy?

We have a strategic global launch plan, which is influenced by regulatory considerations, market opportunity, and capability to support both commercially and technically in regions around the globe, either directly or with distributors. The initial launch is in Europe, where we have CE mark and a Distribution Agreement with Biocartis NV. In the U.S., we will sell directly to hospitals once we receive 510K FDA clearance, however, for those interested in early access to SeptiCyte RAPID we offer early access programs for evaluation. We will assess each region according to the considerations noted previously.

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