Curetis Completes Sample Enrollment in Unyvero U.S. FDA Trial in Lower Respiratory Tract Infections
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Curetis AG /
Curetis Completes Sample Enrollment in Unyvero U.S. FDA Trial in Lower
Respiratory Tract Infections
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- Last patient enrolled in prospective arm of IVD trial
- More than 2,250 prospective and retrospective samples enrolled in study
- Data to be complemented with up to 500 additional contrived samples with focus
on rare pathogens
Holzgerlingen, Germany, June 28, 2016 -- Curetis N.V. (the "Company" and,
together with Curetis GmbH, "Curetis"), a developer of next-level molecular
diagnostic solutions, today announced the completion of patient enrollment in
its Unyvero U.S. FDA trial. The primary endpoint of the prospective and
retrospective study is the performance of the Unyvero LRT55 Lower Respiratory
Tract cartridge in detecting lower respiratory tract infections as compared to
microbiology culture, the current diagnostic standard of care.
In less than a year, a total of 2,254 tracheal aspirate and bronchoalveolar
lavage samples have enrolled at nine participating sites across the US,
including Mayo Clinic, Northwestern University, Johns Hopkins Hospital, UCLA and
Columbia University Medical Center. 1,698 samples were prospectively tested, and
556 were retrospectively tested with the LRT55 Unyvero Lower Respiratory Tract
Cartridge as well as using standard of care microbiology culture. The Principal
Investigator of the trial is Dr. Robin Patel, Director of the Clinical
Bacteriology Laboratory and Infectious Diseases Research Laboratory, and Chair
of the Division of Clinical Microbiology at Mayo Clinic.
"Our Clinical Trial Operations team would like to thank all of the participating
sites, as well as our Principal Investigator Robin Patel, for their dedicated
support during the study," said Johannes Bacher, Chief Operating Officer of
Curetis. "We are proud to conclude patient enrollment this month as planned,
after running more than 5,650 Unyvero LRT55 Cartridges in a study with complex
sample management logistics."
"We are very pleased to have finished enrolment of our U.S. study on schedule
and according to plan," said Dr. Oliver Schacht, CEO of Curetis. "In preparing
for our IPO during the second half of last year, we outlined a number of
anticipated near- and mid-term milestones for the Company. Following the
commercial launch of our blood culture (BCU) application cartridge earlier this
year, the completion of enrollment in our U.S. trial represents another
important accomplishment from that list. I am proud of what our teams have
accomplished since becoming a public company, and we look forward to the release
of initial top-line data from the study later this year."
After completion of all molecular comparator testing, data will be unblinded and
Unyvero results will be compared against an independent molecular composite
comparator based on pathogen DNA analysis by PCR and sequencing. Completion of
the analysis is expected in the second half of 2016. Subsequently, a statistical
analysis based on more than 350,000 data points combined from microbiology,
Unyvero runs, additional molecular testing and bidirectional sequencing will be
prepared. FDA submission is anticipated before the end of the year, with a goal
of securing FDA clearance for Unyvero and commercialization of the technology in
the first half of 2017.
In order to provide additional data points for certain rare pathogens, e.g.
Legionella, Mycoplasma, Pneumocystis, up to 500 contrived samples from well
characterized pathogen strains from several international strain providers will
be spiked into negative matrix and tested with Unyvero at several clinical trial
sites. It is expected that this phase will add approximately 1,500 cartridge
runs, as double testing will be performed on two systems in parallel for
software validation, including daily controls and a number of sample repeats.
LRT55 is a second-generation cartridge based on the design of the CE-IVD marked
P55 cartridge marketed outside the U.S. It features 40 markers, a novel control
concept and provides the most comprehensive molecular marker panel for lower
respiratory tract infections available today.
Further details about the Unyvero platform are available at the Unyvero product
website - www.unyvero.com.
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. 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 countries across Europe, the
Middle East and Asia.
For further information, please visit www.curetis.com.
About the Unyvero System
The CE-marked Unyvero System is a versatile hardware platform for the detection
of a broad panel of bacteria, fungi and antibiotic resistance genes from a
single sample in one run. It processes a disposable cartridge providing the
necessary reagents to complete the analysis from sample to result. It is
marketed in Europe, Russia, the Middle East and various other non-European
countries, with three CE-marked Unyvero Application Cartridges currently
available: The Unyvero P55 Cartridge focuses on pneumonia testing, the ITI
Cartridge is designed for the diagnosis of implant & tissue infections and the
BCU Cartridge is designed to analyze positively flagged blood culture samples
from bottles inoculated with blood from patients with suspected blood stream
infections. Cartridges for additional indications are in various stages of
development and preparation.
In the U.S., Curetis is running a prospective multi-center clinical trial aimed
at achieving FDA clearance registered here.
The platform enables the DNA-based testing of all clinically relevant samples in
a fully automated, unsupervised analysis process requiring only a few, quick
manual preparation steps. The analysis thus can be performed with minimal
operator time and without the need of skilled staff or special infrastructure.
Thereby, clinically relevant information is available within about four to five
hours to support an informed therapy decision as early as possible.
For further information, please visit www.unyvero.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.
According to §§ 190 ff. German Reorganization Act (UmwG) and by way of enrolment
in the commercial register at district court Stuttgart on March 15, 2016 Curetis
plc (AG) changed its legal form into Curetis Ltd. (GmbH).
Contact
Curetis GmbH
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
pr(at)curetis.com
www.curetis.com - www.unyvero.com
International Media 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 Inquiries
The Ruth Group
Lee Roth
lroth(at)theruthgroup.com
Tel. +1 646 536 7012
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Unternehmensinformation / Kurzprofil:
Datum: 28.06.2016 - 07:40 Uhr
Sprache: Deutsch
News-ID 480232
Anzahl Zeichen: 11475
contact information:
Town:
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Kategorie:
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