OpGen Announces Publication of Results from Major Clinical Study Using Unyvero Hospitalized Pneumonia (HPN) Panel in the Lancet Respiratory Medicine
May 26 2022 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease,
announced today the release of a new peer-reviewed journal
publication from a major investigator-initiated, multicenter,
randomized, controlled and interventional trial conducted at two
tertiary care centers in Switzerland (University Hospital of Basel
and Kantonsspital St. Gallen). The trial demonstrates that using
Unyvero HPN panel in hospitalized pneumonia patients for the
examination of bronchoalveolar lavage (BAL) in combination with
antibiotic stewardship decreases the duration of inappropriate
antibiotic therapy of hospitalized patients with pneumonia at risk
for Gram-negative bacteria and supports antibiotic de-escalation in
66% of patients.
In this publication titled “Fast multiplex bacterial PCR of
bronchoalveolar lavage for antibiotic stewardship in hospitalized
patients with pneumonia at risk of Gram-negative bacterial
infection (Flagship II): a multicentre, randomized controlled
trial1,” the authors assessed the clinical utility and impact of
the Unyvero panel in hospitalized adult patients with suspicion of
pneumonia, a clinical indication for bronchoscopy and at risk for
infection with Gram-negative bacteria. The primary study endpoint
was duration of inappropriate antibiotic therapy defined as the
time in hours on inappropriate antibiotic therapy from bronchoscopy
to discharge or up to 30 days after bronchoscopy. Secondary
endpoints were time to clinical stability, length of hospital stay
in days, mortality within 30 days, adverse events (safety), and
diagnostic performance of the Unyvero panel assessed for BAL
compared with conventional microbiological testing.
A total of 740 patients with pneumonia were screened; 208
eligible patients were randomized of whom 100 were assigned to the
intervention group (also referred to as the PCR group); in this
intervention group, the BAL specimen was analyzed by conventional
culture as well as determination of Gram-negative bacteria using
the Unyvero HPN panel; the other 108 patients were randomized to
the control group where the BAL sample was analyzed solely by
conventional microbiology culture. The Unyvero results for
Gram-negative bacteria were disclosed to the attending physician
treating the patients in the intervention group approximately 5
hours after bronchoscopy.Several key findings emerged:
- The duration of inappropriate antibiotic treatment was
decreased by 39 hours in the PCR group; Unyvero reduced the
duration of inappropriate antibiotic therapy to 47 hours (vs. 86
hours in the control group), p<0.0001. The low P-value suggests
a high statistical significance of this result.
- Inappropriate antibiotic therapy was reduced by 45% in the
Unyvero group (p<0.0001).
- The overall duration of antibiotic therapy was 22.5% shorter in
the Unyvero group.
- Patients treated in the Unyvero group had a three times higher
probability of appropriate antibiotic therapy (p<0.0001).
- A reduction in the use of broad-spectrum antibiotics or
decreasing the amount of antibiotics in the Unyvero group did not
have any adverse effects on clinical stability, ICU admission,
hospital readmission or 30-day mortality, compared to the control
group.
- Gram-negative bacteria in BAL were detected more commonly by
Unyvero than conventional microbiological culture in 39 patients
vs. in 30 patients, respectively.
On diagnostic performance, the authors commented that “the
accuracy of bacterial PCR is usually measured using culture as the
reference standard, although microbiological culture is far from
being an optimal gold standard due to its diagnostic performance.”
In this study, they showed that Unyvero has a higher sensitivity
than conventional microbiological culture when clinical syndrome or
imaging is used as the reference standard.
The authors concluded that “this study is the first multicenter,
randomized controlled trial showing that results from a multiplex
bacterial PCR panel of bronchoalveolar lavage incorporated into
antibiotic stewardship translate into less inappropriate antibiotic
therapy. Accordingly, the duration of inappropriate antibiotic
therapy was reduced in the PCR group with no compromise in clinical
outcomes, including time to clinical stability, length of stay in
the hospital, and mortality.”
Faranak Atrzadeh, OpGen’s Chief Marketing and Scientific Affairs
Officer commented: “Pneumonia caused by Gram-negative bacteria is
often associated with poor diagnosis and a high mortality rate.
This multicenter, randomized, interventional study demonstrates the
importance of rapid and accurate molecular diagnostics and the
significant and actionable impact of the Unyvero hospitalized
pneumonia panel on timely initiation of antibiotic therapy in
patients with pneumonia.”
About Unyvero Lower Respiratory Tract and Hospitalized
Pneumonia PanelsThe Unyvero Hospitalized Pneumonia (HPN)
panel detects 21 clinically relevant pathogens and 17 antibiotic
resistance markers in less than five hours directly from native
specimens with only around two minutes of hands-on time, compared
to routine bacterial cultures that can take up to several days for
confirmatory pathogen identification and antimicrobial
susceptibility testing results. In the U.S., the Unyvero LRT and
LRT BAL panels for rapid detection of lower respiratory tract
infections such as pneumonia are FDA-cleared for tracheal aspirate
samples and bronchoalveolar lavage fluids, respectively. Unyvero
HPN and LRT BAL are the only syndromic multiplex PCR panels for
lower respiratory tract infections that also include Pneumocystis
jirovecii, a causative agent of Pneumocystis pneumonia (PCP) and a
key fungal pathogen often found in immunocompromised patients that
can be difficult to diagnose.
About OpGen, Inc. OpGen,
Inc. (Rockville, MD, USA) is a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease. Along with our
subsidiaries, Curetis GmbH and Ares Genetics GmbH,
we are developing and commercializing molecular microbiology
solutions helping to guide clinicians with more rapid and
actionable information about life threatening infections to improve
patient outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs. OpGen’s product
portfolio includes Unyvero®, Acuitas® AMR Gene Panel and
the ARES Technology Platform including ARESdb®, using NGS
technology and AI-powered bioinformatics solutions for antibiotic
response prediction.
For more information, please visit www.opgen.com.
Forward-Looking StatementsThis press release
includes statements regarding the publication of results of a
recent clinical study of the Unyvero Hospitalized Pneumonia panel.
These statements and other statements regarding OpGen’s future
plans and goals constitute "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934 and are intended to
qualify for the safe harbor from liability established by the
Private Securities Litigation Reform Act of 1995. Such statements
are subject to risks and uncertainties that are often difficult to
predict, are beyond our control, and which may cause results to
differ materially from expectations. Factors that could cause our
results to differ materially from those described include, but are
not limited to, the success of our commercialization efforts, our
ability to successfully, timely and cost-effectively develop, seek
and obtain regulatory clearance for and commercialize our product
and services offerings, the rate of adoption of our products and
services by hospitals and other healthcare providers, the fact that
we may not effectively use proceeds from recent financings, the
continued realization of expected benefits of our business
combination transaction with Curetis GmbH, the continued
impact of COVID-19 on the Company’s operations, financial results,
and commercialization efforts as well as on capital markets and
general economic conditions, our ability to satisfy debt
obligations under our loan with the European Investment Bank,
the effect of the military action
in Russia and Ukraine on our distributors,
collaborators and service providers, our liquidity and working
capital requirements, the effect on our business of existing and
new regulatory requirements, and other economic and competitive
factors. For a discussion of the most significant risks and
uncertainties associated with OpGen's business, please
review our filings with the Securities and Exchange
Commission. You are cautioned not to place undue reliance on these
forward-looking statements, which are based on our expectations as
of the date of this press release and speak only as of the date of
this press release. We undertake no obligation to publicly update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
OpGen:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and
PRmatt@fischtankpr.com
OpGen Investor Contact:Alyssa
FactorEdison Groupafactor@edisongroup.com
____________________________1
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00086-8/fulltext
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