Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, has announced that SeptiCyte® RAPID has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The cleared test is an aid in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis.

Immunexpress has been a leader in host response sepsis diagnostics, and this second FDA clearance translates its biomarker technology to the sample-to-answer Biocartis Idylla™ near-patient testing platform.

SeptiCyte® RAPID 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 process is fully automated in a user-friendly, hands-free format, and a result is obtained in one hour.

"SeptiCyte® RAPID has the potential to transform sepsis diagnosis, addressing a critically unmet need in the ICU," said Roy Davis, M.D., Ph.D., Chief Medical Officer of Immunexpress. "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."

Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress, commented, "It has been a long journey to transfer our clinically proven novel biomarker technology from our 8 hour FDA-cleared SeptiCyte® LAB product in 2017, to the advanced 1 hour sample-to-answer Biocartis Idylla™ testing platform. This FDA clearance could not have been achieved without the dedication of the Immunexpress team, the support of our investors, and our clinical partners around the globe."

The increasing incidence of sepsis, which has accelerated with the COVID 19 pandemic, is well recognized and has been generally attributed to the growing prevalence of chronic conditions in aging populations.

The clinical presentation of sepsis is often hard to identify early; fever is not always present, and it can often go unrecognized clinically for extended periods. Sepsis remains a leading cause of morbidity and mortality among intensive care unit (ICU) patients. For each hour that treatment initiation is delayed after diagnosis, sepsis-related mortality increases by approximately 8%. Therefore, maximizing effective care requires early recognition and initiation of treatment protocols. SeptiCyte® RAPID will be the first FDA-cleared test to differentiate sepsis from non-infectious systemic inflammation to aid in a sepsis diagnosis within approximately one hour for patients suspected of sepsis.

FDA clearance was based on data from retrospective and prospective studies validating the clinical accuracy of SeptiCyte® RAPID.

The retrospective clinical study included 8 sites in the United States and Europe from the MARS clinical trial (NCT01905033) and VENUS clinical trial (NCT02127502).

The prospective study, NEar PatienT MolecUlar TestiNg in SEpsis (NEPTUNE), evaluated real-time performance of SeptiCyte® RAPID in a clinical setting at Emory University, Rush University and the University of Southern California. In both retrospective and prospective studies, the sepsis status of patients was determined by a three-member panel of expert physicians. 

The data reinforces the utility of quickly testing the patient's immune host response to determine if there is an underlying sepsis infection. Immunexpress will immediately commercialize SeptiCyte® RAPID to ensure broad availability across the United States in 2022.

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