Sepsis, a condition often more dangerous than heart attacks and strokes combined, is among the most deadly, costly, and complex challenges hospitals face today. Ajay Shah, the CEO of Cytovale, a medical diagnostics company based in San Francisco, emphasized the severity of sepsis and the critical need for rapid identification and treatment. In light of these challenges, Cytovale has developed IntelliSep, an early detection test for sepsis, which has recently begun implementation in several health systems.
Froedtert & the Medical College of Wisconsin Health Network is the latest to adopt IntelliSep, following its FDA clearance in December 2022. The test was first used commercially in August of the previous year at Our Lady of the Lake Regional Medical Center in Louisiana. These developments mark significant milestones in the test’s deployment and its potential impact on sepsis management.
IntelliSep offers unique advantages in diagnosing sepsis, especially in the critical and often chaotic environment of hospital emergency departments (EDs), where over 80% of sepsis cases are presented. The efficiency of the test is significant since the mortality rate for sepsis increases up to 8% for every hour treatment is delayed. Within approximately 8 minutes of running a blood sample, IntelliSep enables clinicians to determine a patient’s risk of sepsis. This rapid diagnostic capability is vital because the initial hours in the ED are crucial for setting a patient on the correct care pathway.
The technology underpinning IntelliSep involves analyzing the white blood cells’ response to infection, which differs between septic and non-septic patients. A proprietary algorithm assesses these changes to predict sepsis likelihood. This method not only distinguishes IntelliSep from other market offerings but also fits seamlessly into existing ED and laboratory workflows. Unlike other sepsis tests, which might require complex sample handling or are not tailored for emergency department settings, IntelliSep uses a small sample of whole blood from a standard EDTA blood draw – a common practice in EDs.
Cytovale’s IntelliSep test primarily stands out because it directly measures the cells’ dysregulated host response, a key indicator of sepsis, making it the only test of its kind cleared for emergency department use. This feature differentiates it from other products by companies like BioFire Diagnostics, Accelerate Diagnostics, and Redcliffe Labs, which target a broader range of inpatient and urgent care settings.
In practice, Our Lady of the Lake Regional Medical Center has reported notable improvements in both clinical outcomes and cost-efficiency since incorporating IntelliSep into their workflow. They noted a 30% reduction in mortality rates from sepsis and an average saving of nearly $1,500 per patient tested. These outcomes underscore the potential benefits of IntelliSep in enhancing patient care and reducing hospital expenditures related to sepsis management.
In summary, IntelliSep represents a significant advancement in the timely and accurate diagnosis of sepsis, particularly in the high-pressure environment of emergency departments. Its compatibility with standard medical procedures and its ability to rapidly evaluate a patient’s risk of sepsis could transform how this deadly and complex condition is managed in hospitals, potentially saving both lives and resources.
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