OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, today announced the release of a
new peer-reviewed publication that demonstrates that the Unyvero
Hospitalized Pneumonia (HPN) panel is a reliable and rapid
diagnostic test with high negative predictive value for the
detection of bacterial pathogens directly from native lower
respiratory tract samples, allowing identification of bacterial
co-infections in hospitalized patients with COVID-19 pneumonia in
just five hours.
Performance of the Unyvero HPN was evaluated
against standard of care (SoC) microbiological testing for
detection of bacterial pathogens in lower respiratory tract
specimens obtained from hospitalized COVID-19 patients with a
clinical suspicion of secondary bacterial infection. These samples
were collected during the first wave of the COVID-19 pandemic in
Stockholm, Sweden (March 2020 through June 2020). A total of 83
samples were obtained from 68 patients, consisting of 61 (73.5%)
tracheal secretions, 11 (13.4%) bronchoalveolar lavage, 8 (9.7%)
protected specimen brush (PSB), 2 (2.4%) bronchial secretions, and
1 (1.2%) sputum sample. One sample each was obtained from 57 unique
patients, two samples each from 7 patients, and three samples each
from 4 patients. The mean age among the study subjects was 58.8
years old, and 74% were male and 26% were female.
Final results of this study have now been
published in the European Journal of Clinical Microbiology &
Infectious Diseases and found that the Unyvero HPN panel provides
accurate detection of common agents of bacterial pneumonia with an
overall high negative predictive value of 99.8% for pathogen
detection. This could potentially allow for reduction in
unnecessary antibiotic use and supporting antibiotic stewardship
efforts. The overall positive percent agreement (PPA, sensitivity)
and negative percent agreement (NPA, specificity) with culture for
detection and identification of bacteria that grow in routine
cultures were 95.1% and 98.3%, respectively, which is consistent
with the performance of the Unyvero Lower Respiratory Panels (LRT
and LRT BAL) that have been published recently by Mackenzie E.
Collins and colleagues1 and Matthias Klein et al2.
The study also demonstrated several advantages
of the Unyvero HPN panel, including higher diagnostic yield
compared to SoC culture alone, which enabled the identification of
additional clinically important pathogens such as Staphylococcus
aureus, Pseudomonas aeruginosa, Serratia marcescens, Haemophilus
influenzae, Stenotrophomonas maltophilia, among several others in
25% of cases that were missed by microbiological methods.
Furthermore, data demonstrated that Unyvero HPN could detect
bacterial pathogens from patient samples that were negative by
culture initially, but when subsequent cultures were ordered on
these patients during the later course of their hospital stay they
were in fact positive for the same pathogen. This indicates that
the HPN panel can detect potential pathogens earlier than culture,
which may enable earlier treatment and management of patients.
In their publication titled “The Unyvero
Hospital-Acquired pneumonia panel for diagnosis of secondary
bacterial pneumonia in COVID-19 patients3” the authors highlight
the fact that “Current estimates suggest that nearly 80% of the
patients admitted in the ICU with COVID-19 receive antibiotics. It
is most likely possible that the bacterial super-infections among
COVID-19 patients admitted to critical care units are due to the
longer durations of stay in the ICU and mechanical ventilation,
rather than the viral infection itself, but nonetheless this
requires diligent microbiological testing because the signs and
symptoms can be similar and confounding.”
Antibiotic therapy in the absence of etiological
diagnosis of infection has both clinical and public health
implications. Inappropriate use of antibiotics is a
well-established driver for the emergence of antimicrobial
resistance among bacterial pathogens. The authors further comment
that “Given this context, the Unyvero HPN panel can be a potential
rapid diagnostic test of choice, considering that the panel is able
to detect 20 bacterial species, one fungus and 17 antimicrobial
resistance genes that includes the most common infectious etiology
of both healthcare- and ventilator-associated pneumonia.” They
conclude that “Unyvero HPN demonstrated a higher diagnostic yield
than culture; it is significantly faster, with turnaround time of
<5 hours from sample to results compared with average of 2.5
days for culture, providing clinicians earlier data to inform
antimicrobial decisions, especially in critically ill COVID-19
patients and the upcoming flu season.”
“Rapid and accurate detection is essential to
assess bacterial pneumonia co-infections in critically ill COVID-19
patients. We are pleased about this final data being published as
it highlights the strong performance and utility of the Unyvero HPN
Panel as a culture-independent comprehensive diagnostic tool to
help with detection of bacterial pneumonia earlier in the hospital
journey of these patients for more prompt and appropriate
treatment” said Faranak Atrzadeh, Chief Marketing and Scientific
Affairs Officer of OpGen.
The 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. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with 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 Acuitas®
Lighthouse, 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 Statements by
OpGen
This press release includes statements regarding
the results of a recent study of OpGen’s Unyvero HPN panel and its
potential clinical benefits. These statements and other statements
regarding OpGen’s Unyvero products, their commercialization and
launch, 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, 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, including our
February 2021 and November 2020 financings, the realization of
expected benefits of our business combination transaction with
Curetis GmbH, the success of our commercialization efforts, the
impact of COVID-19 on the Company’s operations, financial results,
and commercialization efforts as well as on capital markets and
general economic conditions, 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 Contact:Oliver
SchachtCEOInvestorRelations@opgen.com
Press Contact:Matthew
BretziusFischTank Marketing and PRmatt@fischtankpr.com
Investor Contact:Megan
PaulEdison Groupmpaul@edisongroup.com
1 https://jcm.asm.org/content/jcm/58/5/e02013-19.full.pdf
2 https://jcm.asm.org/content/early/2020/12/15/JCM.02497-20
3 https://link.springer.com/content/pdf/10.1007/s10096-021-04194-6.pdf
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