“Sepsis is more deadly than heart attack and stroke combined — in fact it’s the deadliest, costliest, and arguably most complex condition facing hospitals today.”
Those remarks came from Ajay Shah, CEO of San Francisco-based medical diagnostics startup Cytovale. This week, a third health system started using the company’s early sepsis detection test, called IntelliSep — Froedtert & the Medical College of Wisconsin Health Network announced its plans to deploy the test on Wednesday.
IntelliSep was cleared by the FDA in December 2022, and saw its first commercial placement in August of last year when Our Lady of the Lake Regional Medical Center in Louisiana began using the test.
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Sepsis symptoms vary greatly and often imitate those of other infections and conditions, which make it difficult for clinicians to quickly and accurately detect, Shah explained.
“Add to the challenge the fact that over 80% of sepsis cases present to the emergency department, where diagnostic speed and accuracy is critical since mortality from sepsis increases by up to 8% for each hour that it goes untreated. A patient’s care pathway is largely determined in the ED, so accuracy is paramount,” he declared.
Cytovale provides a rapid diagnostic in the emergency room that lets clinicians know if a patient has or could develop sepsis, Shah said. It is the first FDA-cleared rapid diagnostic test indicated for use in the emergency department, he added.
When a patient comes to the emergency department, clinicians can quickly screen them with IntelliSep by taking a blood sample and running the test in the hospital lab. After about 8 minutes, they can access the results, Shah noted.
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“The technology squeezes the white blood cells from a blood sample and characterizes their response to an infection – which differ between septic and non-septic patients – and then a proprietary algorithm characterizes the changes and predicts the patient’s likelihood of sepsis,” he explained.
There are several other tests on the market that identify sepsis across inpatient and urgent care settings, such as those made by BioFire Diagnostics, Accelerate Diagnostics and Redcliffe Labs.
However, IntelliSep is the only test focused on measuring the cells’ dysregulated host response and cleared for use in the emergency department, Shah argued.
“Additionally, unlike some other approaches, IntelliSep fits readily into existing ED and laboratory workflows, since the test uses a small whole blood aliquot from a standard EDTA blood collection, which is something commonly collected during an ED workup,” he remarked.
Shah also pointed out that Our Lady of the Lake Regional Medical Center is seeing significantly improved clinical outcomes and cost savings after one year of using IntelliSep.
The emergency department has reduced mortality rates from sepsis by 30%, as well as saved an average of nearly $1,500 per patient tested with IntelliSep, he noted.
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