Curetis Expects Near-Term U.S. FDA Decision on 510(k) Clearance of Unyvero LRT for BAL Specimens
25 Novembre 2019 - 8:00AM
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All formal FDA requests for additional information
answered
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Interactive review ongoing as review nears
completion
Amsterdam, the Netherlands,
Holzgerlingen, Germany, and San Diego, CA, USA, November 25,
2019, 08:00 am CET -- Curetis N.V. (the
"Company" and, together with its subsidiaries,
"Curetis"), a developer of next-level molecular
diagnostic solutions, today announced that the Company has filed
its formal response to the FDA’s AI (Additional Information request
letter regarding the Company’s filing for 510(k) clearance of the
Unyvero LRT – Lower Respiratory Tract Application Cartridge for
bronchoalveolar lavage (BAL) samples. The formal response addressed
all additional information requested by FDA regarding the original
submission filed on July 23, 2019. The Company now expects a
near-term clearance decision.
Pneumonia patients are often treated empirically
with broad spectrum antibiotic therapy. The Unyvero LRT Application
Cartridge provides laboratorians and clinicians a powerful
diagnostic tool to identify pathogens in lower respiratory tract
infections quickly and reliably, and supports stewardship efforts
to avoid unnecessary antibiotics.
In April 2018, Unyvero LRT was cleared by the
U.S. FDA for tracheal aspirates for the diagnosis of lower
respiratory tract infections such as pneumonia. To also offer a
solution for the testing of BAL samples, Curetis in July 2019 filed
for 510(k) clearance of a Unyvero LRT Application Cartridge
optimized for use with BAL specimens, Unyvero LRT BAL. Together,
tracheal aspirates and BAL samples are the most common specimen
types used in the diagnosis of these infections. It is estimated
that BAL specimens account for half of the samples obtained for the
diagnosis of lower respiratory tract infections. The comprehensive
LRT BAL panel covers the most clinically relevant microbial and
fungal pathogens and antibiotic resistances in this indication
area.
The 510(k) submission was based on clinical data
from a cohort of patient samples collected at nine sites during the
Company’s U.S. FDA LRT trial. Further, a cohort of additional
retrospective samples known to be positive for one or more
pathogens was tested with Unyvero LRT BAL. Using these cohorts, the
study compared the performance of the Unyvero LRT BAL Application
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 LRT BAL Cartridge delivers comprehensive,
accurate, and fast testing for lower respiratory tract infections
in under 5 hours, with only a few minutes of hands-on time, whereas
the standard-of-care based on microbiology culture methods often
required several days 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.
“With the response to the additional information
request letter filed last Friday, we expect that FDA’s review of
our submission is nearing completion,” said Johannes Bacher, COO of
Curetis, “and we are expecting a final clearance decision in the
near term. We believe that clearance of the Unyvero LRT BAL
Application Cartridge for this additional sample type will increase
the total addressable market for Unyvero in the U.S., substantially
giving us more opportunities to place Unyvero instruments for rapid
testing of patients with suspected lower respiratory tract
infections.”
###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 offers next-generation solutions for infectious disease
diagnostics and therapeutics. The ARES Technology Platform combines
what the Company believes to be the 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 an offer to subscribe for 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,” “targets,” “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’ Contact DetailsCuretis
N.V.Max-Eyth-Str. 4271088 Holzgerlingen, GermanyTel. +49 7031
49195-10pr@curetis.com or ir@curetis.comwww.curetis.com
- www.unyvero.com
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
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