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Cytovale's Diagnostic Test Demonstrates Strong Performance in Rapid Identification of Sepsis Risk, Peer-Review Study Confirms

3 May, 2024

Cytovale®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced the publication of a new peer reviewed-study in "Academic Emergency Medicine'' that demonstrates strong diagnostic performance of the company's IntelliSep® host response test for sepsis detection. The study analyzed 1,002 patients and evaluated the accuracy of IntelliSep to rapidly diagnose patients with sepsis and help clinicians expedite appropriate care.

"The impressive diagnostic and prognostic performance of IntelliSep seen in this study is comparable to results seen for critical tests used for other emergent conditions seen in the Emergency Department (ED), such as heart attack and pulmonary embolism," said Dr. Hollis O'Neal, a Pulmonary and Critical Care Physician for LSU New Orleans and Medical Director of Research for Our Lady of the Lake Health. "This study shows enormous promise for the first-ever objective measure of immune activation. With a tool like IntelliSep, ED providers can be armed with the knowledge they need to guide potentially septic patients to the appropriate care pathway."

The IntelliSep test is the only test of its kind that is U.S. Food and Drug Administration (FDA)-cleared for detecting sepsis in an adult population that presents with signs and symptoms of infection to the Emergency Department. The test provides critical new information about immune activation and sepsis risk stratification through a simple blood draw in about 8 minutes.

This study is a pooled analysis of 1,002 patients composed of five distinct, but similar, adult cohorts who presented in seven geographically diverse EDs across the U.S. with signs or suspicion of infection. IntelliSep was evaluated for accurately diagnosing sepsis and providing a rapid, objective tool for determining the risk and severity of sepsis in these patients. Among the findings, key highlights include:

IntelliSep demonstrated impressive 'rule-out' performance related to sepsis, with a Negative Predictive Value of 97.5%, which, combined with the 0.0% sepsis mortality rate for patients with low risk scores, may allow the care team to explore alternative diagnoses in low risk patients.
The test showed similar 'rule-in' performance to other critical ED tests, with a Positive Predictive Value of 55%.
More than 50% of the patients observed were classified by the IntelliSep test as having a low risk of sepsis, yet, the number of these patients treated with antibiotics was comparable to the number of patients treated with antibiotics that received a high risk score.

"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," said Dr. O'Neal.

"This study provides the most comprehensive picture of IntelliSep data available to date. It highlights the potential impact of the IntelliSep test on clinical outcomes and the potential savings that hospitals may achieve through more efficient and effective sepsis care," said Cytovale CEO Ajay Shah.

Cytovale is currently working with selected early access partners to integrate the IntelliSep test into their ED screening processes. Recent data from Our Lady of the Lake Regional Medical Center, a large academic medical center in Baton Rouge, La. and early adopter of the test, found that when IntelliSep was integrated early in an ED sepsis diagnosis protocol it significantly reduces length of stay for IntelliSep tested patients, resulting in a savings of $1,429 per patient.

About Cytovale®
Cytovale is committed to improving human health by pioneering early detection technologies powered by insightful assessment of immune activation. Comprised of an extraordinary team of life scientists, engineers, clinicians, and dreamers, Cytovale intends to accelerate the time it takes to get from triage to life-saving therapies. Learn more about Cytovale and request to implement IntelliSep® in your hospital or care setting through


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