Immunexpress has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its one-hour and direct-from-blood sepsis test called SeptiCyte RAPID.
Using reverse transcription polymerase chain reaction (PCR), the gene expression assay will quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene blood RNA tube.
Designed to use along with clinical assessments, vital signs and laboratory findings, the SeptiCyte RAPID will help differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis.
Based on the increasing likelihood of infection-positive systemic inflammation, the SeptiCyte RAPID generates a score (SeptiScore) that falls within discrete interpretation bands.
Immunexpress chief medical officer Dr Roy Davis said: “SeptiCyte RAPID has the potential to transform sepsis diagnosis, addressing a critically unmet need in the ICU.
“SeptiCyte RAPID has been evaluated in hospitals since 2019. Major hospital systems with which we have worked are anxiously waiting to incorporate this into the current diagnostic tool set, allowing clinicians to make swift and accurate clinical decisions, ultimately improving patient outcomes.”
The FDA clearance is based on data from retrospective and prospective studies, which validated the clinical accuracy of SeptiCyte RAPID test.
Consisting of MARS clinical trial and VENUS clinical trial, the retrospective clinical study was conducted at eight sites in the US and Europe.
The prospective study, NEar PatienT MolecUlar TestiNg in SEpsis (NEPTUNE), assessed real-time performance of SeptiCyte RAPID in a clinical setting at Emory University, Rush University and the University of Southern California.
A three-member panel of expert physicians determined the sepsis status of patients in both retrospective and prospective studies.
The SeptiCyte RAPID test, which is intended for in-vitro diagnostic use, is designed for use on the Biocartis Idylla system.
To make wider availability across the US in 2022, Immunexpress aims to immediately commercialise SeptiCyte RAPID test.
