-
Broad Unyvero LRT BAL panel also includes atypical
pathogens such as Pneumocystis jirovecii
-
Clearance expected to substantially increase total
addressable market for Unyvero System in the U.S.
-
Commercial launch in the U.S. expected for
Q1-2020
Amsterdam, the Netherlands,
Holzgerlingen, Germany, and San Diego, CA, USA, December 20,
2019, 23:30 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 received
510(k) clearance by the U.S. Food and Drug Administration (FDA) to
market its Unyvero LRT Lower Respiratory Tract Application
Cartridge for use with bronchoalveolar lavage (BAL) samples to
diagnose lower respiratory tract infections such as pneumonia. The
LRT BAL panel detects a broad spectrum of clinically relevant
causative agents, including atypical pathogens, as well as
antibiotic resistance markers. Thereby, it provides clinicians with
a valuable diagnostic tool that informs early and supports
appropriate antibiotic treatment decisions in this indication.
Infections with atypical pathogens are often
associated with community-acquired pneumonia (CAP), but are not
considered in the context of hospital-acquired or
ventilator-associated pneumonia. Therefore, hospitalized patients
usually are not tested for these organisms unless there is a
suspicion of infection. Further, empiric treatment of these
patients does not normally cover atypical pathogens. Unyvero LRT
BAL expands the diagnostic capability of clinicians to routinely
identify atypical infections that might otherwise escape detection
and hence can prevent prolonged inappropriate treatment of
patients.
Furthermore, the Unyvero LRT BAL application is
the first and only FDA cleared molecular diagnostic pneumonia panel
that includes Pneumocystis jirovecii. As culture-based diagnosis of
Pneumocystis jirovecii Pneumonia (PJP) is not possible,
identification of this pathogen is often based on morphological
detection techniques, which are labor-intensive and time-consuming
and lack sensitivity. Rapid diagnosis of PJP, which causes severe
and life-threatening symptoms, is crucial in patients with a weak
or suppressed immune system. Initiating the appropriate therapy
even one day earlier can significantly reduce mortality in this
patient group.
“Pneumocystis jirovecii is a leading cause of
pneumonia in immunocompromised individuals. Several features unique
to Pneumocystis make its diagnosis difficult. No combination of
symptoms, signs, and chest radiographic findings is diagnostic of
Pneumocystis Pneumonia, the organism cannot be cultured, and its
diagnosis currently relies on microscopic visualization of the
characteristic cysts and/or trophic forms on stained respiratory
specimens,“ said Richard G. Wunderink, MD, Professor of Medicine,
Pulmonary Critical Care, Northwestern University Feinberg School of
Medicine, and Medical Director, Medical ICU, Northwestern Memorial
Hospital. “Inclusion of Pneumocystis jirovecii in a rapid
comprehensive molecular panel for BAL, the preferred diagnostic
procedure for Pneumocystis Pneumonia, will greatly facilitate our
ability to quickly diagnose and treat these patients.”
Indiscriminate overuse and misuse of antibiotics
are key drivers of dramatically spreading antibiotic resistance, a
substantial global health threat. A report recently issued by the
Centers for Disease Control and Prevention (CDC) revealed that
drug-resistant bacteria and fungi cause almost 3 million infections
and 35,000 deaths a year in the United States, meaning that
antibiotic-resistant pathogens cause a serious infection every 11
seconds and a death every 15 minutes (Ref. 1).
By providing a fast and reliable solution for
the rapid detection of pathogens and antibiotic resistance markers,
Unyvero LRT BAL is an essential, indispensable tool for targeted
antimicrobial therapy improving patient outcomes while facilitating
stringent antibiotic stewardship.
“Unyvero LRT had already been cleared by the
U.S. FDA for tracheal aspirate samples in April 2018,” said
Johannes Bacher, COO of Curetis. “With our new Unyvero LRT BAL
Application Cartridge, clinicians and hospitals can now also test
bronchoalveolar lavage samples. This sample type accounts for about
half of the samples obtained for the diagnosis of lower respiratory
tract infections such as pneumonia. As a result, our Unyvero
solution is offering the most comprehensive multiplex molecular
panel for the rapid diagnosis of bacteria and fungi associated with
severe pneumonia. It not only enables rapid and simultaneous
detection of pathogens but also offers the broadest coverage of
resistance markers.”
“We expect that the clearance of our LRT panel
for BAL samples will significantly increase the total addressable
market for our Unyvero System in the U.S.,” said Oliver Schacht,
PhD, CEO of Curetis. “It will provide us with substantial
opportunities to place Unyvero instruments for rapid testing of
patients with suspected lower respiratory tract infections.
Moreover, by providing laboratorians and clinicians with a powerful
diagnostic tool to identify pathogens in lower respiratory tract
infections earlier, faster and more reliably, Unyvero supports
antibiotic stewardship efforts to avoid the unnecessary use of
antibiotics.”
With commercial launch preparations underway,
the Company expects to make Unyvero LRT BAL broadly available to
U.S. customers in Q1-2020.
###Reference 1)
CDC. Antibiotic Resistance Threats in the United States, 2019.
Atlanta, GA: U.S. Department of Health and Human Services, CDC;
2019. The full 2019
AR Threats Report, including methods and appendices, is available
online at www.cdc.gov/DrugResistance/Biggest-Threats.html.
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
- 20191220_Curetis_PR_BAL_FDA_approval_FINAL
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