> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Immunexpress Rapid Sepsis Diagnostic Cleared
- URL: https://www.fdaweb.com/immunexpress-rapid-sepsis-diagnostic-cleared/
- Published: 2021-12-01T12:00:00.000Z
- Updated: 2026-09-14T17:24:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150681

FDA has cleared an Immunexpress 510(k) for its SeptiCyte Rapid, a diagnostic aid for use in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis. The device contains all the reagents needed for “quantification of gene expression using a reverse transcription polymerase chain reaction (PCR) to determine the relative expression levels of host response genes directly from whole blood,” the company says, adding that a result is obtained in one hour. Testing is performed using the company’s Biocartis Idylla testing platform.

Immunexpress says the clearance was based on data from retrospective and prospective studies validating the device’s clinical accuracy. “The retrospective clinical study included eight sites in the United States and Europe from the MARS clinical trial (NCT01905033) and VENUS clinical trial (NCT02127502),” the company says. The NEPTUNE prospective study evaluated real-time performance of SeptiCyte Rapid in a clinical setting at Emory University, Rush University and the University of Southern California. “The data reinforces the utility of quickly testing the patient's immune host response to determine if there is an underlying sepsis infection,” it says.