Curetis Files for U.S. FDA Clearance for Unyvero Platform and LRT Application Cartridge
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Curetis Files for U.S. FDA Clearance for Unyvero Platform and LRT Application
Cartridge
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Curetis Files for U.S. FDA Clearance for Unyvero Platform and LRT Application
Cartridge
- Final panel demonstrates overall weighted average sensitivity of 91.4% and
overall weighted average specificity of 99.5% across all lower respiratory tract
panel pathogens
- Unyvero results available after approximately five hours only, compared to
three to four days on average for microbiology culture based methods
Amsterdam, the Netherlands, and Holzgerlingen, Germany, January 05, 2017 -
Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a
developer of next-level molecular diagnostic solutions, today announced it has
submitted a 510(k) application to the U.S. Food and Drug Administration for its
Unyvero Platform and the Unyvero LRT Lower Respiratory Tract Cartridge. The
submission is for the use of Unyvero for the diagnosis of lower respiratory
tract infections. The LRT panel includes up to 36 analytes for all key pathogens
and antibiotic resistances in this indication area
The submission is based on clinical data of the Company's U.S. FDA trial
comparing the performance of the Unyvero LRT Lower Respiratory Tract Cartridge
in detecting respiratory pathogens to microbiology culture, the current
diagnostic standard of care. The trial also compared Unyvero results to a
composite of microbiology and independent PCR tests plus sequencing. The study
included a total of 2,202 prospective and retrospective samples and met its
primary endpoints by demonstrating an overall weighted average sensitivity of
91.4% across all pathogens of the final panel definition as well as an overall
average weighted specificity of 99.5%, which increased to 99.8% after discrepant
result resolution. The Unyvero application delivered microorganism and
resistance marker results in approximately 5 hours, whereas microbiology culture
methods required three to four days on average until microorganism
identification and antibiotic susceptibility testing of a sample has been
completed.
The study was complemented by a set of contrived samples, i.e. negative patient
samples spiked with rare pathogens and analytes at known concentrations. This
part was successfully completed at four trial sites with data showing an overall
weighted average positive percent agreement (PPA) for all tested pathogens of
87.6%. All in all, more than 10,000 LRT cartridges were run in the trial,
including comprehensive analytical and pre-clinical testing.
Together with the participating study centers, Curetis is preparing a
publication of the clinical trial data. An abstract will be submitted for peer
review and for presentation at one of the major upcoming U.S. medical
diagnostics conferences.
"With the timely submission of our FDA filing for Unyvero and the LRT
Application Cartridge, we have met yet another key milestone as laid out during
our IPO," said Johannes Bacher, COO of Curetis. "The trial resulted in a very
comprehensive and strong data package that will hopefully allow for getting a
clearance decision in 2017 and has confirmed the substantial reduction in time-
to-result that can be achieved with Unyvero."
"With the first FDA trial completed, we are well on track towards launching our
Unyvero Platform in the USA in 2017," added Dr. Oliver Schacht, CEO of Curetis.
"To that end, we have recently completed recruitment of a core team at our San
Diego office with the hires of Rick Betts as our Director Marketing from Abaxis
and Faranak Atrzadeh as Director Scientific Affairs, who was most recently at
GenMark. Once we have clarity on the FDA process and timelines, we will start
building a field-based sales and service organization and a back-office support
team of around 20 additional staff during 2017. In addition, we will continue to
drive additional Application Cartridges and Menu expansions by conducting
further U.S. FDA trials."
Curetis has already started preparations for another FDA trial with its Unyvero
ITI Application Cartridge for the diagnosis of joint infections, including
periprosthetic joint infections. The Company expects to launch this trial in
2017 with the aim of completion in 2018.
###
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 has signed collaboration agreements with Heraeus Medical and
Cempra Inc. as well as several international distribution agreements covering
many countries across Europe, the Middle East and Asia.
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
20170105_Curetis_PR_EN:
http://hugin.info/171382/R/2069131/777219.pdf
Curetis_Logo:
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Source: Curetis via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 05.01.2017 - 07:44 Uhr
Sprache: Deutsch
News-ID 515896
Anzahl Zeichen: 9576
contact information:
Town:
Holzgerlingen
Kategorie:
Business News
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