Curetis Announces Positive Top Line Data from U.S. FDA Trial
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Curetis Announces Positive Top Line Data from U.S. FDA Trial
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- Primary endpoint for Unyvero LRT product for lower respiratory tract
infections shows overall weighted average sensitivity of 90.2% and overall
weighted average specificity of 99.3%
- U.S. FDA submission being prepared
Amsterdam, the Netherlands, and Holzgerlingen, Germany, October 25, 2016 --
Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a
developer of next-level molecular diagnostic solutions, today announced top line
data from its successfully completed Unyvero U.S. FDA trial. The trial was
designed to compare the performance of the Unyvero Instrument Platform and the
Unyvero LRT Lower Respiratory Tract Cartridge in detecting lower respiratory
tract infections to microbiology culture, the current diagnostic standard of
care. Additionally, the trial compared Unyvero results to a composite of
microbiology and independent PCR tests plus sequencing. The prospective and
retrospective study met its primary endpoint by demonstrating an overall
weighted average sensitivity of 90.2% and an overall average weighted
specificity of 99.3%.
The trial included a total of 2,203 prospective and retrospective samples and
has run 5,694 Unyvero Cartridges, including daily positive and negative controls
at each site as well as reproducibility tests. Tracheal aspirate and
bronchoalveolar lavage samples were collected at nine participating sites across
the U.S., namely Beaumont Health, Columbia University, Johns Hopkins, Mayo
Clinic, Northwestern University, Summa Health, UCLA, University of Rochester,
and University of Washington. Of these samples, 1,654 were prospectively and
549 were retrospectively tested with the Unyvero LRT Lower Respiratory Tract
Cartridge, with standard of care microbiology culture and with additional
molecular diagnostic assays.
Furthermore, the study will be complemented with data from more than 400
contrived samples from well-characterized pathogen strains obtained from several
international strain providers. These strains were spiked into negative patient
samples and are currently undergoing testing with Unyvero at several clinical
trial sites in order to provide additional data points for certain rare
pathogens.
Overall, more than 1,100 samples tested positive for one or more pathogens on
the LRT panel. Data were available from Unyvero cartridges, from microbiology
culture and from independent molecular testing using PCR and sequencing,
resulting in a total of more than 350,000 data points. These data are fully
consistent and in line with the performance evaluation previously conducted by
Curetis for CE IVD marking in Europe, as well as published data from various
European KOLs and customer sites.
Based on these data, Curetis is now preparing its final package for a 510(k)
submission for the Unyvero Platform and the LRT Cartridge to the U.S. FDA in due
course. The company is expecting feedback from the FDA in the first half of
2017.
"We are truly excited about completing the study on time and as planned and
generating a strong and very comprehensive data set," said Dr. Oliver Schacht,
CEO of Curetis. "We have now started compiling the final submission documents
and are looking forward to receiving feedback from the FDA. We will be working
closely with the agency in the coming months."
"This is a very broad molecular panel for diagnosis of lower respiratory tract
infection," said Principal Investigator 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. "It includes
numerous bacteria and resistance genes as well as one fungus. Beyond panel
breadth, the test yields faster results than those achieved using traditional
culture."
###
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 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
20161025_Curetis_PR_EN:
http://hugin.info/171382/R/2051121/767398.pdf
Curetis_Logo:
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Source: Curetis via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 25.10.2016 - 08:43 Uhr
Sprache: Deutsch
News-ID 502509
Anzahl Zeichen: 8212
contact information:
Town:
Holzgerlingen
Kategorie:
Business News
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