First One-Hour, Direct-from-Blood Sepsis Test Receives FDA Clearance

A fully automated diagnostic tool quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis.

Immunexpress, Inc. (Seattle, WA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SeptiCyte RAPID test as an aid in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis.

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 is 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. 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."

"It has been a long journey to transfer our clinically proven novel biomarker technology from our eight hour FDA-cleared SeptiCyte LAB product in 2017, to the advanced one hour sample-to-answer Biocartis Idylla testing platform," added Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress. "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."

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