-
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@curetis.com or ir@curetis.com
www.curetis.com - www.unyvero.com
International Media &
Investor Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info(@)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@theruthgroup.com
Tel. +1 646 536 7012
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