Our Lady of The Lake Regional Medical Center

First hospital to implement Cytovale's IntelliSep® sepsis diagnostic tool realizes significant clinical and financial returns in first nine months of screening SAN FRANCISCO, June 20, 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 that the first hospital to commercially implement the company's IntelliSep® rapid sepsis diagnostic has now screened over 5,000 patients with the test. Our Lady of the Lake Regional Medical Center, part of the Franciscan Missionaries of Our Lady Health in Baton Rouge, La., added the IntelliSep test to the hospital's sepsis management program in August 2023 and the technology has become a critical first-line triage tool to quickly detect or rule-out sepsis in the emergency department (ED). Sepsis is the most costly condition for U.S. hospitals, in large part because clinicians have not had a rapid diagnostic to objectively detect sepsis. The IntelliSep test generates results in about eight minutes using a standard blood draw, and can be seamlessly and efficiently integrated into existing ED care workflows. According to a recently presented study, the test enabled the Our Lady of the Lake Regional Medical Center team to shorten the length of stay of IntelliSep-tested patients by an average of 1.28 days and significantly decrease the amount of blood cultures drawn and antibiotics delivered. This may translate into lower risks for patients, decreased time away from family and work, and fewer unnecessary interventions and antibiotic exposure. The study also documented savings of about $1,429 per patient tested. "As a mission-driven healthcare provider, Franciscan Missionaries of Our Lady Health System is committed to the highest level of sepsis care for the communities we are privileged to serve," said Christopher Thomas, M.D., vice president and chief quality officer at Franciscan Missionaries of Our Lady Health System and Critical Care Physician at Louisiana State University Health Sciences Center. "Given improvements in recognition, time to treatment and sepsis mortality that we have realized through utilizing IntelliSep, we have decided to incorporate the test in each of our major facilities." Terri White, a patient who checked into Our Lady of the Lake Regional Medical Center's ED last fall after experiencing a combination of fever, fatigue, constipation and abdominal pain, knows firsthand that having access to a rapid sepsis diagnostic can be lifesaving. Within minutes of taking the IntelliSep test, she was flagged as high-risk for having sepsis and immediately "pulled out of the waiting room" and admitted for treatment. "When I was told that I had sepsis, I was shocked and also scared, because I didn't realize I was so sick. It was a miracle that I went to Our Lady of the Lake Regional Medical Center instead of another hospital, because I might not be alive today if I had not walked through their doors," White recalled. IntelliSep is U.S. Food and Drug Administration-cleared for rapid diagnosis of sepsis in adults with signs and symptoms of infection who present to the ED, where 80% of sepsis cases initially present. What sets IntelliSep apart from other sepsis tools is that the test introduces a novel marker that indicates sepsis by directly examining white blood cell dysregulation at a single-cell level, a key driver of sepsis. A recent peer-reviewed study published in "Academic Emergency Medicine'' concluded that IntelliSep correctly identified which patients didn't have sepsis 98% of the time, making it an essential tool for physicians to rule-out sepsis and explore alternative diagnoses. About Cytovale® Cytovale is committed to improving patient care by pioneering early detection technologies that assess immune activation to accelerate the time it takes to get from triage to life-saving therapies. Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, IntelliSep®, leverages machine learning and advanced microfluidics to provide Emergency Department clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep measures the dysregulated immune system response to infection that would indicate sepsis and generates results in about eight minutes using a standard blood draw. Cytovale is based in San Francisco and venture-backed by Norwest Venture Partners, Sands Capital and Global Health Investment Corporation (GHIC). For more information, visit and follow Cytovale on LinkedIn and X. SOURCE Cytovale

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. View original content to download multimedia: SOURCE Cytovale

Study presented at the International Symposium on Intensive Care and Emergency Medicine Conference IntelliSep, when integrated early in an ED sepsis diagnosis protocol, significantly reduces length of stay for admitted patients, resulting in a savings of $1,429 per patient SAN FRANCISCO, March 19, 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 new data that demonstrates how its IntelliSep® test reduced cost of care and improved efficiency of sepsis care for a large U.S. academic center. The study – "The Fiscal Impact of a Rapid Sepsis Diagnostic in the Emergency Department (ED)" – was independently conducted by Our Lady of the Lake Regional Medical Center and was presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM 2024) Conference. Sepsis is the leading cause of death and the costliest condition in U.S. hospitals. Because the risk of death increases by up to 8% for each hour that sepsis treatment is delayed, there is a critical need for early detection technologies. IntelliSep is the first of its kind U.S. Food and Drug Administration (FDA)-cleared rapid diagnostic for sepsis indicated for use in the Emergency Department to detect the dysregulated host response to infection that would indicate sepsis. The test generates results in about 8 minutes using a standard blood draw, and can be seamlessly and efficiently integrated into existing care workflows. The study examining IntelliSep's impact on sepsis care for patients presenting to the ED included 196 control and 413 intervention patients at Our Lady of the Lake Regional Medical Center, a large academic medical center in Baton Rouge, La. Compared to controls, patients whose care was informed by IntelliSep testing spent less time in the hospital and benefited from more efficient triage, resulting in significant cost savings. On average, the study showed that IntelliSep-informed care led to cost savings of: $3,624 per inpatient admitted to the intensive care unit (ICU), associated with 2.42 day reduction in average length of stay (LOS) for these patients $1,930 per non-ICU inpatient, associated with a 1.28 day reduction in average LOS $243 per observation patient Taken together, this study showed an average cost savings of $1,429 per patient across the entire IntelliSep tested cohort. In addition to this study, Our Lady of the Lake Regional Medical Center has also reported a reduction in needle sticks and antibiotic exposure for patients due to increased accuracy in sepsis detection. "IntelliSep is an entirely new way of approaching sepsis detection. It creates the standard for hospitals to rapidly cut through clinical uncertainty and definitively identify sepsis to improve patient care," said Christopher Thomas, M.D., vice president and chief quality officer at Franciscan Missionaries of Our Lady Health System and Critical Care Physician at Louisiana State University Health Sciences Center. "Roughly 20% of patients entering the ED are at risk for sepsis and delayed diagnosis often leads to lengthy hospital stays and increased use of resources. With IntelliSep, we're able to improve patient centered outcomes and accelerate time to treatment for high-risk patients. The combination of cost savings for our patients, paired with a faster time to return home to their families, is a game changer." 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. SOURCE Cytovale