The Food and Drug Administration (FDA) has cleared Cytovale’s IntelliSep® test for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing.
The semi-quantitative test uses a whole blood sample to assess cellular host response by analyzing the biophysical properties of white blood cells. The 10-minute test is intended for use in adults with signs/symptoms of infection who present to the emergency department. Results are categorized into 1 of 3 interpretation bands (IntelliSep Index) based on the probability of sepsis (Band 1 indicating low probability and Band 3 indicating high probability).
The IntelliSep test was evaluated in a blinded, prospective, observational, multicenter cohort study (CV-SQuISH-ED; ClinicalTrials.gov Identifier: NCT04933760); the primary analysis included 572 evaluable patients who ranged in age from 18 years to 103 years and presented to the emergency department. These patients had infections affecting or originating from all major organ systems. The test was performed on a whole blood sample that was obtained within 4 hours of triage. Patients were then subsequently followed with retrospective chart review.
To validate the diagnostic performance of IntelliSep, test scores were compared with nonreference retrospective physician adjudication, per the Sepsis-3 definition. Results showed a clear relationship between the IntelliSep Index and the increasing likelihood of sepsis within 3 days.
“Quickly identifying sepsis is critical to saving lives, but until now, we’ve lacked a reliable tool to either recognize the condition or explore alternate diagnoses,” said Hollis O’Neal, MD, 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 on the multicenter CV-SQuISH-ED study that supported the clearance. “IntelliSep is truly a game changer for sepsis because it provides a unique indicator that gets to the heart of the current sepsis definition, immune dysregulation. The test provides hospital staff with the information needed to identify and treat septic patients efficiently and reduce the financial and health burdens of overtreatment for hospitals and patients.”
The test is expected to be available in the coming weeks.
- FDA clears Cytovale’s® IntelliSep® Sepsis Test, first in a new class of emergency department-focused diagnostic tools. News release. January 18, 2023. https://www.businesswire.com/news/home/20230118005120/en/FDA-Clears-Cytovale%E2%80%99s%C2%AE-IntelliSep%C2%AE-Sepsis-Test-First-in-a-New-Class-of-Emergency-Department-Focused-Diagnostic-Tools.
- US Food and Drug Administration. FDA 510(k) premarket notification summary for Intellisep test. Accessed January 18, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220991.pdf.