Late-Breaking Data for Cytovale’s IntelliSep® Sepsis Test Further Validate its Potential to Aid in Rapid, Clinically Actionable Sepsis Diagnosis in Emergency Departments

• Data presented at the 2023 American Thoracic Society International Conference also highlight the potential of the IntelliSep test to help hospitals and health systems improve quality and resource utilization
• The IntelliSep test received U.S. Food and Drug Administration 510(k) clearance in December 2022 as a first-of-its-kind diagnostic for sepsis, a leading driver of death and hospitalization costs in the U.S.

SAN FRANCISCO--(BUSINESS WIRE)-- Cytovale^®, a pioneering medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced today that newly presented data for its IntelliSep^® test further reinforce its potential to aid in rapid, clinically actionable sepsis diagnoses in emergency departments (EDs). These data were presented for the first time today as a late-breaking poster presentation at the American Thoracic Society (ATS) International Conference in Washington, DC. The data from the multi-center CV-SQuISH-ED clinical validation study also supported the U.S. Food and Drug Administration (FDA) 510(k) clearance of Cytovale’s IntelliSep test in December 2022 to aid in the early detection of sepsis for the approximately 30 million adults presenting with signs and symptoms of infection in U.S. EDs each year.

Sepsis is the leading cause of death worldwide and is responsible for more than 350,000 deaths every year in the United States alone—more than opioid overdoses, prostate cancer, and breast cancer combined.^1,2 The IntelliSep test is a groundbreaking diagnostic tool that helps clinicians quickly recognize sepsis to support critical, time-sensitive clinical decisions. It provides a test result, referred to as the IntelliSep Index (ISI), in under 10 minutes, categorizing patients into three bands according to their probability of sepsis, with Band 1 indicating low probability and Band 3 indicating high probability.

“Every minute counts when it comes to sepsis diagnosis, and EDs operate under major time and resource constraints that could impact patient outcomes,” said Dr. Hollis O’Neal, M.D., Medical Director of Research at Our Lady of the Lake Regional Medical Center, Critical Care Physician at LSU Health Sciences Center and National Principal Investigator and presenter for the CV-SQuISH-ED trial. “These results validate the efficacy and efficiency of IntelliSep as a diagnostic aid that may improve sepsis triage when incorporated into existing clinical protocols.”

Data from the CV-SQuISH-ED study underscore IntelliSep’s accuracy in stratifying patients based on risk of sepsis and death, highlighting its potential as an actionable tool for clinicians as part of the clinical decision-making process. In this study, which included 572 patients, the IntelliSep test identified three statistically distinct bands of sepsis probability with an increasing likelihood of sepsis. Furthermore, observational data highlighted that the bands trended strongly with hospital care metrics and sepsis-based mortality. At 28 days, the sepsis-based mortality rate for Band 1 (low sepsis probability) was 0% compared to 2.5% in Band 2 and 4.4% in Band 3 (high sepsis probability). In addition, of those ultimately adjudicated as septic that required escalation of care from the non-critical to critical care unit during their hospitalization, 0% were in Band 1, compared with 58% and 42% in Bands 2 and 3. Importantly, the study observed that similar levels of the Severe Sepsis and Septic Shock Management Bundle (SEP-1) resources were administered across all patients in the study regardless of risk band, highlighting the potential of IntelliSep to help providers focus these limited clinical resources on the patients with the greatest need.^3,4 More comprehensive results have been submitted for publication in a peer-reviewed journal.

Cytovale anticipates making the IntelliSep test commercially available within the next quarter.

About Cytovale

Cytovale is committed to improving human health by pioneering early detection technologies powered by insightful assessment of immune activation. Made up 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. For more information, please visit www.cytovale.com. For updates, follow Cytovale on LinkedIn and Twitter.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50119C00072.

References:
1. What Is Sepsis?, Sepsis Alliance (2022)
2. Sepsis Awareness Study Summary Report, Radius Global Market Research (2019).
3. Jagneaux T., Regunath H., Rosenman L., Mahler S., (May 18, 2021-May 1, 2022). CV-SQuISH-ED: Clinical Validation Study. Identifier NCT04933760. https://clinicaltrials.gov/ct2/show/NCT04933760.
4. O’Neal, Hollis R. Jr., et al. (2023). Validation of a Rapid Sepsis Diagnostic for Use in Patients Presenting to the Emergency Department With Signs or Suspicion of Infection. Poster presented at: American Thoracic Society International Conference; 2023 May 19-24; Washington, DC.

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