Tag Archives: Immunexpress

March 2024—Immunexpress announced FDA clearance of EDTA blood compatible cartridges for use with the SeptiCyte Rapid test. SeptiCyte Rapid is a sample-to-answer, cartridge-based, host response molecular test for sepsis using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood. It is intended for in vitro diagnostic use and runs on the Biocartis Idylla platform.

Dec. 3, 2021—Biocartis announced that the FDA granted 510(k) clearance for its SeptiCyte Rapid test, which was developed under partnership with Immunexpress.

June 2017—Immunexpress received FDA 510(k) clearance for the use of SeptiCyte Lab as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of ICU admission. It is the first RNA-based clinical diagnostic tool, direct from whole blood, to aid medical providers in the early identification of infection in suspected sepsis patients, according to a company statement.