Large scale study confirms Cytovale's
IntelliSep test accurately predicts sepsis risk and severity, aids
in appropriate triage and treatment pathways in emergency
departments
SAN
FRANCISCO, May 2, 2024 /PRNewswire/ --
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 cytovale.com. For updates, follow
Cytovale on LinkedIn and X.
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SOURCE Cytovale