Curetis' Unyvero Intra-Abdominal Infection (IAI) Cartridge Receives CE Marking
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Curetis' Unyvero Intra-Abdominal Infection (IAI) Cartridge Receives CE Marking
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Curetis' Unyvero Intra-Abdominal Infection (IAI) Cartridge Receives CE Marking
- Product to launch in EMEA at ECCMID Conference
April 22-25, 2017
- IAI Panel covers up to 130 diagnostic targets
Amsterdam, the Netherlands, and Holzgerlingen, Germany, April 20, 2017 - Curetis
N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of
next-level molecular diagnostic solutions, today announced the successful
completion of clinical performance evaluation and CE-IVD marking of its fourth
Unyvero Application Cartridge for the diagnosis of severe intra-abdominal
infections (IAI). The IAI Cartridge covers up to 92 bacteria, 13 fungi, 3 toxins
and 22 resistance markers. The panel includes molecular markers for, among
others, Clostridium difficile, Clostridium perfringens, Aeromonas spp. as well
as for difficult-to-cultivate strains such as Prevotella spp., that are often
overlooked in the presence of aerobic / fast-growing microorganisms. It also
comprises important antibiotic resistance markers such as Colistin resistance
marker mcr-1, Fosfomycin resistance marker fosA3 and Nitroimidazol resistance
markers nimA and nimB.
The prospective, multi-center study to evaluate clinical performance was
conducted over the past few months at major hospitals in the UK, in France, and
Italy. In total, 332 patient samples were tested and 679 pathogens were
determined as true positives using the Unyvero IAI Application Cartridge.
Overall weighted average sensitivity for the pathogens specifically targeted by
the test panel was 93.8% at an overall weighted average specificity of 99.7%
following discrepant result resolution.
A particular strength of the IAI cartridge is the reliable detection of
anaerobic bacteria that are notoriously hard to cultivate and thus often missed
by routine microbiological culture. Further, the Unyvero IAI has also
demonstrated the ability to deliver results on pathogens, toxins, and resistance
markers much faster than microbiology culture, the current standard of care.
The IAI Cartridge aims to support clinicians in the fast and reliable diagnosis
of various severe conditions, including peritonitis, cholecystitis and acute
pancreatitis, and addresses a market of up to 1.9 million patients in
hospitalized settings in Europe and the U.S. per year. Together with the Unyvero
System, the IAI Cartridge can process a broad variety of clinical samples
including tissue, ascites in positively flagged blood cultures, and gastric
juice.
Complicated intra-abdominal infections are a common problem. In Germany alone,
there are about 150,000 cases of severe intra-abdominal infections per year. In
the U.S., appendicitis alone affects about 300,000 patients per year and is
responsible for more than 1 million hospital days. Every fourth case of severe
sepsis or septic shock can be attributed to intra-abdominal infections, and
various independent studies show an overall mortality rate of 7.5%.
"We are excited about this fourth unique application now being launched for our
Unyvero System," said Dr. Achim Plum, CCO of Curetis. "The IAI Cartridge
complements our Pneumonia, ITI and BCU cartridges, and further expands our
portfolio of applications for severe infections in hospitalized patients. It
will not only allow existing Unyvero customers to further broaden the use of
their systems, but it will also attract new customer groups."
Dr. Oliver Schacht, CEO of Curetis, added, "The IAI panel is a first in class
and highly differentiated syndromic testing panel and will be followed by new
panels in the areas of severe urinary tract infections, sepsis host response,
expanded panels in respiratory diseases and cardiology-related infections in the
coming years."
###
Disclaimer
CAUTION - Investigational device. Limited by Federal (or United States) law to
investigational use. The information contained in this communication does not
constitute nor imply an offer to sell or transfer any product, and no product
based on the Curetis Unyvero technology is currently available for sale in the
United States of America or Canada. The analytical and clinical performance
characteristics of any Curetis Unyvero product which may be sold at some future
point in time in the U.S. have not yet been established.
###
About Curetis
Founded in 2007, Curetis is a molecular diagnostics company which focuses on the
development and commercialization of reliable, fast and cost-effective products
for diagnosing severe infectious diseases. The diagnostic solutions of Curetis
enable rapid multi-parameter pathogen and antibiotic resistance marker detection
in only a few hours, a process that today can take up to days or even weeks with
other techniques.
To date, Curetis has raised EUR 44.3 million in an IPO on Euronext Amsterdam and
Euronext Brussels and private equity funds of over EUR 63.5 million.
Furthermore, Curetis has entered into a debt financing facility with EIB for up
to EUR 25 million. The company is based in Holzgerlingen near Stuttgart,
Germany. Curetis collaborates with Heraeus Medical, pharmaceutical companies,
and has entered into several international distribution agreements covering many
countries across Europe, the Middle East and Asia.
In 2017, Curetis established Ares Genetics GmbH, a wholly-owned subsidiary of
Curetis GmbH in Vienna, Austria. Ares Genetics is dedicated to maximizing the
R&D and related scientific and business opportunities of the GEAR assets
acquired in 2016 for the entire Curetis Group.
For further information, please visit www.curetis.com.
Legal Disclaimer
This document constitutes neither an offer to buy nor to subscribe securities
and neither this document nor any part of it should form the basis of any
investment decision in Curetis.
The information contained in this press release has been carefully prepared.
However, Curetis bears and assumes no liability of whatever kind for the
correctness and completeness of the information provided herein. Curetis does
not assume an obligation of whatever kind to update or correct information
contained in this press release whether as a result of new information, future
events or for other reasons.
This press release includes statements that are, or may be deemed to be,
"forward-looking statements". These forward-looking statements can be identified
by the use of forward-looking terminology, including the terms "believes",
"estimates", "anticipates", "expects", "intends", "may", "will", or "should",
and include statements Curetis makes concerning the intended results of its
strategy. By their nature, forward-looking statements involve risks and
uncertainties and readers are cautioned that any such forward-looking statements
are not guarantees of future performance. Curetis' actual results may differ
materially from those predicted by the forward-looking statements. Curetis
undertakes no obligation to publicly update or revise forward-looking
statements, except as may be required by law.
Contact details
Curetis
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
pr(at)curetis.com or ir(at)curetis.com
www.curetis.com - www.unyvero.com
International Media & Investor Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info((at))akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
U.S. Media & Investor Inquiries
The Ruth Group
Lee Roth
lroth(at)theruthgroup.com
Tel. +1 646 536 7012
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Source: Curetis via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 20.04.2017 - 08:03 Uhr
Sprache: Deutsch
News-ID 537217
Anzahl Zeichen: 9398
contact information:
Town:
Holzgerlingen
Kategorie:
Business News
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