In a recent chat, Immunexpress‘s chief, Dr. Rollie Carlson, shed light on their breakthrough in battling sepsis — an FDA-approved diagnostic tool designed to save lives by swiftly identifying the condition. This game-changer promises significant improvements for patients under the cloud of sepsis suspicion, shaping a brighter horizon for healthcare efficiency and patient care.
The origin and development of the company: Exploring the initial inspiration and its growth journey
Originally hailing from Australia, Immunexpress made waves in the realm of biomarker discovery, particularly concerning infectious diseases. A pivotal move to Seattle in 2011 marked a significant shift towards tackling sepsis—a life-threatening condition resulting from the body’s extreme and often chaotic response to infection. This condition poses a serious challenge due to its elusive clinical symptoms; its early signs are difficult to pinpoint, with fever not always manifesting.
The challenge doesn’t stop there. Patients suspected of having sepsis could instead be grappling with Systemic Inflammatory Response Syndrome (SIRS), which mirrors sepsis symptoms but stems from non-infectious causes and tends to be less severe. Distinguishing between these two conditions is vital yet challenging—prompting Immunexpress to seek a more accurate diagnostic approach.
For years, the standard procedure for handling potential cases of sepsis has been immediate antibiotic treatment upon symptom presentation. However, this approach raises concerns over misdiagnosis—patients might be battling SIRS or their bodies might not be responding to bacterial infections at all. The consequence? An unnecessary spike in antibiotic use that burdens healthcare providers and undermines efforts aimed at responsible antibiotic stewardship.
To tackle this issue head-on, Immunexpress delved into cutting-edge technologies like microarrays and next-generation sequencing. Their goal was simple: identify specific genes that behave differently during episodes of sepsis compared to SIRS. Success followed hard work as the team managed to isolate a set of genes for further evaluation through clinical studies conducted across eight sites worldwide.
The fruit of their labor was SeptiCyte®, an innovative technology harnessing RNA expression data from white blood cells encountering pathogen invasion—an unmistakable signature of sepsis. With collaborations spanning continents—from the U.S., Australia, Europe—to major health institutions worldwide keen on solving the puzzle that is sepsis diagnosis, time remains an enemy equally formidable as inaccuracies.
Understanding that every second counts when it comes to treating sepsis—with delays increasing mortality risk significantly—the initial diagnostic timeline of six-to-eight hours needed trimming down substantially. Fitting diagnostics within an hour became imperative if real change were ever going to materialize in patient survival rates.
In pursuit of this ambitious target, Immunexpress‘ partnership with Biocartis S.A emerged as a game-changer—culminating in the development of a fully-automated SeptiCyte® cartridge. Compatible with Biocartis’ Idylla™ platform, this innovation streamlined testing processes drastically: draw blood sample >> insert into cartridge >> place on Idylla™ tray >> receive results within 60 minutes outlining patient’s likelihood for developing sepse
This leap forward represents not just technological prowess but also embodies hope—for faster diagnoses means timely treatments; it’s about getting crucial information into doctors’ hands when it matters most—all within an eyeblink by medical standards and making strides towards mitigating one of healthcare’s most pressing challenges effectively.
Understanding Sepsis
Sepsis stands as a significant health challenge, especially within the confines of U.S. hospitals, claiming countless lives each year. Its prevalence is staggering, impacting millions globally, a situation exacerbated by the COVID-19 crisis which has seen figures nearly double due to many associated deaths stemming from viral-induced sepsis. The complexity of its diagnosis adds another layer to the challenge.
Before the pandemic struck with full force, Immunexpress had already made strides in addressing this issue through groundbreaking clinical studies that led to the development of a probabilistic score for detecting sepsis. Their test is particularly noteworthy for its ability to accurately identify those suffering from sepsis and equally important, exclude those not affected by it.
Historically, the blame for sepsis was squarely placed on bacterial infections; however, our understanding has evolved. We now know that viruses, fungi, and even protozoa can be culprits behind this condition.
This broad spectrum of potential causes makes SeptiCyte® RAPID, with its focus on assessing how one’s immune system responds to infection rather than trying to pinpoint the infection’s origin itself, an invaluable tool in today’s healthcare landscape. It’s been proven effective across various cases where patients were battling differing viral and fungal infections, offering hope through consistent and reliable detection capabilities when they’re needed most.
Key problems Immunexpress addresses for sepsis patients and doctors
In hospitals, when doctors think someone might have sepsis, they usually test their blood. However, this method isn’t very quick or always accurate, catching the issue only about 20% of the time. Because of this uncertainty, doctors often have to guess and start treating patients as if they have sepsis right away. Unfortunately, a study from the Netherlands highlighted that almost half of these treatments are unnecessary and could even harm patients needing other kinds of care.
This is where SeptiCyte® RAPID comes into play. It’s a game-changer in swiftly identifying whether a patient truly has sepsis and determining what kind it might be—viral, fungal, or bacterial. This distinction is crucial because it guides doctors on whether or not to use antibiotics, especially given the rising concern over antibiotic-resistant germs.
The beauty of SeptiCyte® RAPID lies in its ability to make quick decisions at critical junctures. Whether a patient is being considered for ICU admission due to symptoms like fever or diarrhea, this test steps in promptly aiding healthcare providers in deciding the next step without delay.
Moreover, educating physicians about sepsis has become increasingly vital amid the pandemic. With COVID-19 bringing new challenges regarding sepsis management into focus, offering webinars and online seminars has been instrumental for medical professionals keen on staying ahead in critical care scenarios.
The link between COVID and sepsis explained simply
Sepsis has emerged as a critical concern in the wake of COVID-19, posing significant complications for those infected. Recognizing the gravity of this issue, researchers have conducted comprehensive studies involving hundreds of individuals battling COVID-19 to validate the effectiveness of a new diagnostic tool. This technology has been tested on over 500 patients, underscoring its potential in addressing sepsis among those affected by the coronavirus.
The pandemic has undeniably strained healthcare systems worldwide, particularly impacting hospital resources and finances. Intensive Care Units (ICUs) have felt this pressure acutely, with an urgent need to allocate beds judiciously to those in dire need. The introduction of this test is timely, offering hope in discerning which patients are at heightened risk of developing severe conditions such as sepsis. By identifying high-risk patients early on, healthcare professionals can prioritize ICU admission and initiate targeted treatments promptly.
This approach not only ensures that critical care resources are used efficiently but also significantly improves patient outcomes by providing immediate intervention for those most susceptible to complications from COVID-19. In essence, amidst the challenges posed by the pandemic, this innovative testing solution stands out as a beacon of progress in managing and mitigating its impact on both patients and healthcare establishments alike.
What is required for this to be the usual treatment method?
The groundbreaking SeptiCyte® RAPID test now stands as the first of its kind approved by the FDA specifically for distinguishing between SIRS and sepsis. This distinction is crucial, as it paves the way toward more accurate diagnoses and treatments. The medical community has recognized its significance through presentations at leading conferences and publications in esteemed journals, highlighting its potential to reshape how sepsis is diagnosed.
The necessity for incorporating SeptiCyte® RAPID into hospital screening processes across the U.S. cannot be overstated. Its ability to enhance patient outcomes makes it a critical addition to current testing protocols. With Medicare CMS closely monitoring and evaluating hospitals based on their management of sepsis patients, there’s an evident disparity in performance among institutions. Thus, standardizing care with advanced diagnostic tools like SeptiCyte® RAPID could serve as a key equalizer, potentially boosting hospital ratings by ensuring consistent and effective patient care.
Beyond improving health outcomes, tackling sepsis efficiently can also ease financial pressures on healthcare facilities. High mortality rates aside, the economic toll from prolonged hospital stays and extensive treatment regimens adds up quickly. By integrating better management practices for sepsis patients—starting with precise diagnostics—hospitals have a golden opportunity to reduce both costs and duration of hospital stays.
In essence, adopting this innovative approach not only promises better health results for patients but also spells significant cost savings for hospitals—a win-win scenario urging swift action towards making it a cornerstone of patient care standards everywhere.
What are Immunexpress’s upcoming objectives?
Immunexpress has recently received FDA approval, which is a significant milestone. This green light allows them to supply hospital systems with test cartridges designed to enhance the management of sepsis, a life-threatening response to infection. The primary aim here is to assist hospitals in unifying their approach towards diagnosing and treating sepsis more effectively, thereby improving patient outcomes.
Despite being a smaller entity in the healthcare sector, Immunexpress has had the backing of committed investors who have seen them through various phases of growth. Now, as they look ahead, there’s an emphasis on gathering additional financial support. This is crucial for not only advancing the commercial presence of their current diagnostic tool, SeptiCyte® RAPID, but also for fueling research into its next iteration – SeptiCyte® RAPID +. This upcoming version promises an even greater diagnostic precision by distinguishing between bacterial and viral infections causing sepsis, including those from COVID-19.
The cornerstone of this advancement lies in early detection and treatment initiation. Speedy and accurate diagnosis can significantly tilt the odds in favor of recovery by ensuring timely and appropriate intervention. Herein lies the essence of precision medicine, offering hope through tailor-made medical care that hinges on cutting-edge diagnostics like SeptiCyte® RAPID.
Supporting these advancements are studies pointing toward the critical nature of rapid response in cases of septic shock; where each moment before administering effective antimicrobial therapy counts towards survival rates (Kumar A et al., 2006). Additionally, recent research underscores similar findings within COVID-19 patient care (Zhou F., et al., 2020), further underscoring the importance of swift medical decision-making during infectious disease outbreaks.
