Curetis to Present Data from Unyvero LRT U.S. FDA Clinical Trial at ASM Microbe
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Curetis to Present Data from Unyvero LRT U.S. FDA Clinical Trial at ASM Microbe
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Curetis to Present Data from Unyvero LRT U.S. FDA Clinical Trial at ASM Microbe
- U.S. data set complemented by recent clinical study data from European
hospital
Amsterdam, the Netherlands, and Holzgerlingen, Germany, April 10, 2017 --
Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a
developer of next-level molecular diagnostic solutions, today announced that
significant clinical data updates on its Unyvero System and P55 / LRT cartridge
for the diagnosis of pneumonia and lower respiratory tract infections will be
presented at ASM Microbe 2017, being held June 1-5 in New Orleans, LA.
Detailed data from Curetis' U.S. FDA clinical study of the Unyvero System and
the LRT cartridge for the diagnosis of lower respiratory tract infections will
be presented by Dr Matthew Sims, Director, Infectious Diseases Research at
Beaumont Research Institute and one of the U.S. FDA study's principal
investigators. Dr Sims will present the study during an oral presentation titled
Multicenter Evaluation of the Curetis Lower Respiratory Tract Infection
Cartridge on the Unyvero-Platform in session 481, "Pneumonia: Novel
Epidemiology, Novel Approaches" (June 5, 2017, 12:15-12:30 PM, Room 208).
In addition, Dr Sims will present clinical data from the portion of the study
conducted at Beaumont Hospital, Royal Oak, MI. His presentation Potential Impact
of Rapid Diagnostics in Management of Suspected Pneumonia, will be given in the
session "Antimicrobial and Diagnostic Stewardship" (June 2, 2017, 12:45-2:45 PM,
Exhibit Hall D, Exhibit and Poster Hall).
The U.S. data on the P55/LRT cartridge are complemented by recent findings of
researchers at the Institute of Medical Microbiology, University Hospital Essen
(Essen, Germany), who published data concluding that the "Unyvero Application is
a useful diagnostic tool for the early and rapid detection of pathogens in
respiratory specimens". They reported a significantly higher detection rate when
using Unyvero as compared to culture methods and a considerably reduced time-to-
result, from a median of 48h to a median of 7.5 hours. The team has tested the
Unyvero P55 pneumonia application cartridge in daily clinical routine with 439
respiratory specimens of 342 patients. Results from the European Study were
presented during this year's 5(th) Joint Conference of the DGHM & VAAM / VAAM
Annual Meeting 2017 and published in Schmidt D et al., Early and Rapid Detection
of Respiratory Pathogens: A Commercial Multiplex PCR Assay in Comparison with
Culture. Biospektrum Abstractbook Microbiology and Infection 2017, Heidelberg
2017, p. 131 - DOI: 10.1007/s12268-017-0772-x).
"We are excited that new clinical data on our Unyvero P55 / LRT cartridges,
which are in line with our findings from various CE performance evaluation
studies, have been published in this peer-reviewed format," said Johannes
Bacher, COO of Curetis. "They demonstrate the performance of Unyvero in terms of
sensitivity and specificity, and also confirm the substantial advantage in terms
of time-to-results. Moreover, we are proud that the data from our U.S. FDA trial
were selected for an oral presentation at the upcoming ASM Microbe meeting.
He added that new studies are upcoming in the U.S. and the EU to further
investigate clinical benefit and impact of the Unyvero P55/LRT cartridge.
###
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 maximize 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
Curetis_Logo:
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20170410_Curetis_PR_EN:
http://hugin.info/171382/R/2095054/792308.pdf
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Source: Curetis via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 10.04.2017 - 07:56 Uhr
Sprache: Deutsch
News-ID 535380
Anzahl Zeichen: 8232
contact information:
Town:
Holzgerlingen
Kategorie:
Business News
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