Immunexpress’s SeptiCyte RAPID for Sepsis Diagnosis Gets FDA’s 510(k) Clearance

Seattle, Wash.-based Immunexpress has been granted the FDA’s 510(k) marketing clearance for its SeptiCyte RAPID test to diagnose sepsis.

The rapid test, which was developed in partnership with Mechelen, Belgium-based Biocartis, runs on Biocartis’ Idylla molecular diagnostics platform.

The test has also earned CE-IVD mark certification.