FDA Clears SeptiCyte® RAPID - The First One-Hour, Direct-From-Blood Sepsis Test

Fully automated diagnostic tool SeptiCyte® RAPID 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

Seattle, WA And Brisbane /PRNewswire/ - Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today 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%^[1]. 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.

About SeptiCyte® RAPID
SeptiCyte® RAPID is a gene expression assay using reverse transcription polymerase chain reaction (PCR) to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene® Blood RNA Tube. SeptiCyte® RAPID is used in conjunction with clinical assessments, vital signs and laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis. SeptiCyte® RAPID generates a score (SeptiScore™) that falls within discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte® RAPID is intended for in-vitro diagnostic use and is used on the Biocartis Idylla™ System.

SeptiCyte® RAPID is CE Marked as a near-patient sample-to-answer test in European Union (EU) member countries and those harmonized with the EU IVD Directive (98/79/EC). As of November 2021, SeptiCyte® RAPID has been FDA cleared for use in hospitalized patients suspected of sepsis.

About Immunexpress
Immunexpress is a molecular diagnostic company, based out of Seattle, committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte® technology can assess a patient's dysregulated immune response by quantifying and analyzing gene expression from whole blood, providing actionable results in about an hour to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID is a lab test for sepsis that combines SeptiCyte® technology with the Biocartis' Idylla™ platform^*, empowering clinicians to swiftly differentiate infection positive (sepsis) from infection negative systemic inflammation in patients suspected of sepsis; diagnosing bacterial sepsis, viral sepsis, or fungal infections. This powerful combination of technologies enhances certainty for early sepsis diagnosis, to improve clinical outcomes and lower healthcare costs.

In March 2020, Immunexpress received CE Marking of SeptiCyte® RAPID and announced a commercialization partnership with Biocartis in Europe. In November 2021, Immunexpress received FDA clearance for SeptiCyte® RAPID.

For more information, visit https://www.immunexpress.com/. Follow Immunexpress on Twitter and LinkedIn.

About Biocartis
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a continuously expanding test menu addressing key unmet clinical needs, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.

^*Immunexpress is licensed to use the Idylla™ trademark from Biocartis NV.

¹ Kumar A et al. Duration of hypotension prior to initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Critical Care Medicine. 2006;(34):1589-1596.