Cytovale's FDA-Cleared Sepsis Diagnostic Triages First 5,000 Patients, Paves Way to New Hospital Protocols for Sepsis Management

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Jun 20, 2024, 09:00 ET

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 www.cytovale.com and follow Cytovale on LinkedIn and X.

SOURCE Cytovale