Immunexpress, Inc., a molecular diagnostic company focused on improving 
outcomes for suspected sepsis patients, has been awarded a grant from the 
Biomedical Advanced Research and Development Authority ("BARDA"), part of the 
Office of the Assistant Secretary for Preparedness and Response at the U.S. 
Department of Health and Human Services (HHS), of up to $599,549 to develop and 
pursue U.S. Food and Drug Administration Emergency Use Authorization (EUA) for 
the host response sepsis test SeptiCyte(R) RAPID which has the potential to 
assess and triage patients with escalating signs of COVID-19 disease.  With the 
funding from BARDA, Immunexpress expects to complete development work necessary 
to validate its role as a triage tool to help identify COVID-19 patients with 
an elevated risk for viral or secondary bacterial sepsis.

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The ongoing COVID-19 pandemic underscores the unmet need for technologies that 
efficiently discriminate patients with mild infection from those that have an 
elevated risk for serious complications, including viral or secondary bacterial 
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 and appropriately assign limited resources.

"The COVID-19 pandemic has exacerbated the need for rapid identification and 
triage of COVID-19 patients at risk of sepsis," stated Rolland D. Carlson, 
Ph.D., Chief Executive Officer of Immunexpress. "Equipping clinicians with the 
best tools to manage patients quickly, safely and appropriately is the first 
step in addressing the high mortality rate associated with sepsis infection in 
COVID-19 patients."

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. 

SeptiCyte(R) 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).

About Immunexpress
Immunexpress is a molecular diagnostic company, founded in Australia 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. 

In March 2020, Immunexpress received CE Marking of SeptiCyte(R) RAPID and 
announced a long-term commercialization partnership with Biocartis in Europe. 

For more information visit http://www.immunexpress.com/. Follow Immunexpress on 
Twitter ( 
https://c212.net/c/link/?t=0&l=en&o=2832003-1&h=548626991&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D2684122-1%26h%3D1977976169%26u%3Dhttps%253A%252F%252Ftwitter.com%252FImmunexpress%26a%3DTwitter&a=Twitter 
) and LinkedIn ( 
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).

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


(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: https://doi.org/10.1016/S0140-6736(20)30566-3

Media Contacts: 
Maggie Beller
Russo Partners, LLC
+1-(646)-942-5631 
Maggie.beller@russopartnersllc.com

SOURCE: Immunexpress, Inc.