The IntelliSep technology enables quick diagnosis of sepsis for adults by squeezing white blood cells to characterise their responses to infection. Credit: Pixel-Shot via Shutterstock.

Medical diagnostics company Cytovale has announced the publication of data that shows its sepsis diagnostics tool IntelliSep has a negative predictive value of 97.5%. 

The FDA-cleared IntelliSep technology enables quick diagnosis of sepsis for adults with signs and symptoms of infection by squeezing white blood cells to characterise their responses to infection. It divides patients into three bands based on their sepsis probability using a standard blood sample – Band 1 indicates a low probability, with the likelihood increasing to Band 3. 

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The data, published in the Academic Emergency Medicine journal, demonstrated that the IntelliSep device correctly identified patients who didn’t have sepsis 97.5% of the time. For patients with low-risk scores, there were no deaths from sepsis which suggests it could help doctors consider other possible diagnoses for these patients. 

The tool also showed a 55% accuracy rate in ruling in sepsis. Despite more than half of the patients being classified as low-risk by IntelliSep, they were still treated with antibiotics at similar rates to patients with high-risk scores. 

The study enrolled 1,002 patients from US-based emergency departments who showed signs of infection. The IntelliSep tool was used to quickly diagnose and assess the severity of the sepsis. 

The test was launched in August 2023, following a 510(k) clearance from the US Food and Drug Administration (FDA) in January 2023. Cytovale raised $84m in Series C funds last year to expand the rollout of the IntelliSep test. The funding round was led by Northwest Venture Partners, with participation by additional new investors Sands Capital and Global Health Investment Corporation. 

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Sepsis is a severe, potentially life-threatening condition triggered by the body’s extreme response to an infection. It can lead to widespread inflammation, blood clotting, and organ damage. Sepsis requires prompt medical attention and treatment with antibiotics, emphasising the importance of effective diagnostic tools. 

According to a report on GlobalData’s Pharma Intelligence Center, there will be 2,794,568 diagnosed incident cases of severe sepsis in the seven major markets (UK, US, France, Spain, Germany, Italy, and Japan) in 2030. 

GlobalData is the parent company of Clinical Trials Arena. 

In the announcement accompanying the data, pulmonary and critical care physician for LSU New Orleans Hollis O’Neal said: “These findings spotlight how IntelliSep enables clinicians to detect sepsis earlier in patients for whom the condition wasn’t otherwise suspected. Conversely, IntelliSep also provides an objective tool for clinicians to rule out sepsis and move onto an alternative diagnosis.”