Country for PR: United States
Contributor: PR Newswire New York
Thursday, March 26 2020 - 17:00
Immunexpress Receives CE Mark and Signs European Commercialization Partnership for SeptiCyte(R) RAPID
SEATTLE and BRISBANE, Australia, March 26, 2020 /PRNewswire-AsiaNet/ --

- SeptiCyte(R) RAPID can swiftly differentiate infection positive (sepsis) from 
infection negative systemic inflammation in patients suspected of sepsis 

- Commercialization of SeptiCyte(R) to triage COVID-19 patients will be the 
focus of Biocartis partnership in Europe 

Immunexpress ( 
), Inc. a molecular diagnostic company focused on improving outcomes for 
suspected sepsis patients, today announced it has received CE Marking of 
SeptiCyte(R) RAPID for its host response technology. SeptiCyte(R) RAPID 
combines SeptiCyte(R) technology with the Biocartis Idylla(TM) platform, 
providing actionable results in about one hour to guide the physician to 
optimize patient management decisions. 

Logo - 

The CE Marking of SeptiCyte(R) RAPID is a significant accomplishment for 
Immunexpress, enabling the company to market and sell the near-patient 
sample-to-answer test in European Union (EU) member countries and those  
harmonized with the EU IVD Directive (98/79/EC). Immunexpress plans to 
immediately initiate commercial operations in Europe, and announced a long-term 
commercialization partnership with Biocartis NV, an industry leader in the 
molecular diagnostic space. Biocartis currently has over 1,300 Idylla(TM) 
instruments installed throughout the world.  

"Achieving the CE IVD registration and entering commercialization of 
Immunexpress' leading host response SeptiCyte technology represents a new and 
exciting phase for our company," said Rolland Carlson, Ph.D., Chief Executive 
Officer of Immunexpress. "We believe Biocartis, with its well established and 
growing customer base, will be highly effective in delivering to the European 
community a new and novel sepsis diagnostic tool, designed to enhance the 
certainty of early and rapid sepsis diagnosis, to improve clinical outcomes and 
to lower healthcare costs."

The ongoing COVID-19 pandemic underscores the unmet need for technologies that 
efficiently discriminate patients with mild infection from those that may 
develop serious complications related to sepsis, especially when critical 
medical resources are in short supply. In a recent study of the risk factors 
associated with COVID-19 mortality, sepsis was the most frequently observed 
complication(1). The early diagnosis of bacterial and viral sepsis with 
SeptiCyte(R) RAPID, including the immediate and overwhelming global need to 
triage COVID-19 patients with worsening prognoses, will ensure rapid initiation 
of sepsis management protocols increasing the potential to save lives.

Dr. Carlson continued, "Together with Biocartis, Immunexpress is committed to 
mitigating the constraints on hospitals that are affected by the COVID-19 
pandemic. We are urgently working towards improving patient outcomes by swiftly 
triaging COVID-19 patients to receive the most appropriate treatment. Accurate 
diagnostic testing of sepsis is more important now than ever to enable 
physicians to make rapid clinical decisions in resource-constrained ICUs."

About SeptiCyte(R) RAPID

SeptiCyte(R) 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(R) Blood 
RNA Tube. SeptiCyte(R) 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(R) RAPID generates a score 
(SeptiScore(TM)) that falls within one of three discrete Interpretation Bands 
based on the increasing likelihood of infection-positive systemic inflammation. 
SeptiCyte(R) RAPID is intended for in-vitro diagnostic use and is used on the 
Biocartis Idylla(TM) System.

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(TM) platform is a fully automated 
sample-to-result, real-time PCR 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 in oncology. This represents the 
fastest growing segment of the MDx market worldwide. Today, Biocartis offers 
tests supporting melanoma, colorectal and lung cancer. More information: Follow us on Twitter: @Biocartis_.

About Immunexpress
Immunexpress is a molecular diagnostic company, founded in Australian and based 
out of Seattle, Washington, USA, committed to improving outcomes for patients 
suspected of sepsis. Immunexpress' SeptiCyte(R) technology can assess a 
patient's immune response by quantifying and analyzing gene expression 
signatures from whole blood, providing actionable results in about an hour to 
guide the physician in optimizing patient management decisions. SeptiCyte(R) 
RAPID combines SeptiCyte(R) technology with the Biocartis' Idylla(TM) 
platform*, empowering clinicians to swiftly differentiate infection positive 
(sepsis) from infection negative systemic inflammation in patients suspected of 
sepsis. This powerful combination of technologies enhances certainty for early 
sepsis diagnosis, to improve clinical outcomes and lower healthcare costs. For 
more information visit

Follow Immunexpress on Twitter ( 
) and LinkedIn ( 

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

Media Contacts: 
Maggie Beller
Russo Partners, LLC
+1(646) 942-5631

(1)Zhou, F., et al. (2020) Clinical course and risk factors for mortality of 
adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. 
The Lancet. DOI: 

SOURCE: Immunexpress, Inc.