- Final LRT BAL panel demonstrates overall weighted
average sensitivity of up to 94.7% and overall weighted average
specificity of up to 98.4%
- Unyvero provides results after approximately five
hours, compared to an average of several days for standard-of-care
methods
Amsterdam, the Netherlands, San Diego,
CA, USA and Holzgerlingen, Germany, July 23, 2019, 08:00 am
CEST - Curetis N.V. (the "Company" and,
together with Curetis USA Inc. and 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 LRT Lower Respiratory Tract Cartridge for use with BAL
(bronchoalveolar lavage) specimens. The submission is for use of
Unyvero LRT BAL for the diagnosis of lower respiratory tract
infections such as pneumonia. The LRT BAL panel covers 50
diagnostic targets with 30 assays for the most clinically relevant
pathogens and antibiotic resistances in this indication area.
The submission is based on clinical data from a
cohort of patient samples collected at nine sites during the
Company’s U.S. FDA LRT trial as well as a cohort of additional
retrospective samples known to be positive for one or more
pathogens, comparing the performance of the Unyvero LRT BAL Lower
Respiratory Tract Cartridge in detecting respiratory pathogens to
the current diagnostic standard of care, i.e. microbiology culture.
The trial also compared Unyvero results to a composite comparator
of microbiology and independent PCR tests plus DNA sequencing. In
total, the study included more than 1,400 patient samples from the
combined prospective and retrospective cohorts and demonstrated an
overall weighted average sensitivity of 90.1% and 94.7% and an
overall average weighted specificity of 98.4% and 97.9% across all
pathogens in the prospective and retrospective cohorts,
respectively. The Unyvero application delivered microorganism and
resistance marker results in approximately 5 hours, whereas the
standard-of-care based on microbiology culture methods required
several days on average to complete microorganism identification
and antibiotic susceptibility testing of a patient sample.
The study was complemented by an additional set
of 240 contrived samples, which successfully confirmed performance
of LRT BAL with negative patient samples that were spiked with rare
pathogens and resistance markers at known concentrations. All in
all, more than 5,500 LRT BAL cartridges were run as part of the
comprehensive analytical and clinical performance evaluation.
Furthermore, independent clinical evaluation
data for the Unyvero LRT BAL Application Cartridge from an
investigator-initiated study has recently been presented at the ASM
Microbe 2019 conference in San Francisco, CA, USA, confirming the
excellent sensitivity and specificity of the panel.
“With the submission of our FDA filing for the
Unyvero LRT BAL Application Cartridge, we have met another key
milestone laid out for mid-2019,” said Johannes Bacher, COO of
Curetis. “The clinical validation has resulted in a very
comprehensive and strong data package to support a clearance
decision by the FDA later in 2019 and has once again shown the
substantial reduction in time-to-result that can be achieved with
Unyvero.”
“With this second FDA submission filed, we are
well on track towards expanding the utility of our Unyvero LRT
panel in the USA to also include BAL specimens in addition to
tracheal aspirates,” added Oliver Schacht, CEO of Curetis. “We will
continue to drive evaluations and adoption of our Unyvero
Application Cartridges, and we also look to further menu expansions
and conducting clinical trials e.g. in support of a U.S. FDA
submission of our IJI Invasive Joint Infection Application
Cartridge as additional funding becomes available.”
###
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
Curetis N.V.’s (Euronext: CURE) goal is to
become a leading provider of innovative solutions for molecular
microbiology diagnostics designed to address the global challenge
of detecting severe infectious diseases and identifying antibiotic
resistances in hospitalized patients.
Curetis’ Unyvero System is a versatile, fast and
highly automated molecular diagnostic platform for easy-to-use,
cartridge-based solutions for the comprehensive and rapid detection
of pathogens and antimicrobial resistance markers in a range of
severe infectious disease indications. Results are available within
hours, a process that can take days or even weeks if performed with
standard diagnostic procedures, thereby facilitating improved
patient outcomes, stringent antibiotic stewardship and
health-economic benefits. Unyvero in vitro diagnostic (IVD)
products are marketed in Europe, the Middle East, Asia and the
U.S.
Curetis’ wholly owned subsidiary Ares Genetics
GmbH is developing next-generation solutions for infectious disease
diagnostics and therapeutics. The ARES Technology Platform combines
the presumably most comprehensive database worldwide on the
genetics of antimicrobial resistances, ARESdb, with advanced
bioinformatics and artificial intelligence.
For further information, please visit
www.curetis.com and www.ares-genetics.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 GmbHMax-Eyth-Str.
4271088 Holzgerlingen, GermanyTel. +49 7031 49195-10pr@curetis.com
or ir@curetis.comwww.curetis.com
Curetis International Media &
Investor InquiriesakampionDr. Ludger Wess / Ines-Regina
Buth Managing Partnersinfo@akampion.comTel. +49 40 88 16 59 64Tel.
+49 30 23 63 27 68
-
20190723_Curetis_PR_EN_FDA_Submission_LRT_BAL_final_approved
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