OpGen Announces Publication of Results of Unyvero Hospitalized Pneumonia (HPN) Panel for Detection of Bacterial Respiratory Tract Pathogens from Serial Specimens Collected from Hospitalized COVID-19 Patients
June 22 2022 - 7:00AM
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 study conducted at Karolinska University
Hospital (KUH), Solna, Stockholm, Sweden. The publication
highlights the ability of the Unyvero Hospitalized Pneumonia panel
in detecting potential pneumonia pathogens earlier than culture or
very early during an infection.
The performance characteristics of the Unyvero Hospitalized
Pneumonia panel, in comparison with microbiological culture for
detection of bacterial pathogens from lower respiratory tract
samples obtained from critically ill COVID-19 patients, were
recently published1 by the investigators at Karolinska Institute.
The study results demonstrated that Unyvero HPN provides a higher
diagnostic yield than bacterial culture. This enables reliable and
rapid diagnosis of pathogens of concern in these patients directly
from native lower respiratory tract samples, and provides
identification of bacterial co-infections in hospitalized patients
with COVID-19 pneumonia in just five hours.
In their new publication titled “Evaluation of a pneumonia
multiplex PCR panel for detection of bacterial respiratory tract
pathogens from serial specimens collected from hospitalized
COVID-19 patients2”, the investigators conducted a follow-up study
aimed to examine the concordant and discrepant results comparing
the Unyvero HPN and culture results for detection of microorganisms
from serial specimens collected from the same patient.
Sixty-nine samples obtained from 27 adult subjects (fifteen
patients with two, nine patients with three, and three patients
with four samples collected on separate days) admitted in the
intensive care unit with COVID-19 were included. Data was
categorized based on full concordance (results from Unyvero were
identical for the presence or absence of one or more pathogens by
culture), concordance by correlation (Unyvero was positive for a
pathogen that was negative by culture from the same sample but was
positive by culture in a previous or a subsequent sample from the
same patient within ±7 days), partial concordance (Unyvero detected
the same pathogens that were detected by culture plus additional
pathogen(s) that were not detected by culture and failed achieving
concordance by correlation), discordance (an on-panel pathogen was
culture positive but was not detected by Unyvero; discordant
results were also considered when a sample had only one pathogen
detected by Unyvero but was not detected by culture), concordance
and discordance (samples that were positive for more than one
pathogen by Unyvero but was not detected by culture; one pathogen
was concordant by correlation by culture in a previous or a
subsequent sample from the same patient within ±7 days, the other
pathogen was not detected by culture)._______________1
https://link.springer.com/content/pdf/10.1007/s10096-021-04194-6.pdf2
https://link.springer.com/content/pdf/10.1007/s10096-022-04466-9.pdf
Results were analyzed in two ways: The first evaluation
(Evaluation I) was performed in a typical manner for a comparative
study where Unyvero results were compared with culture results per
subject. The second evaluation (Evaluation II) explored
interpretation of Unyvero false positive results which were then
corroborated by culture from a different sample taken at a later or
at an earlier time point from the same patient. In this approach,
all Unyvero false positives results were considered true positives,
if culture confirmed this result for any other sample (collected at
an earlier or later time point) from the same subject. The latter
approach highlights an important point because published literature
reports sensitivity, specificity, positive predictive value (PPV)
and negative predictive value (NPV) comparisons with the assumption
that conventional microbiologic techniques are 100% sensitive and
specific when in fact microbiological culture is acknowledged to be
far from being an optimal gold standard due to its diagnostic
performance3.
Several key findings emerged in this study:
- Unyvero detected at least one additional pathogen in 20/69
(29%) of the samples tested.
- The additional pathogens detected by Unyvero in 12/20 (60%)
samples were detected by culture from a previous or a subsequent
sample collected (± 7 days) and tested from the same subject in six
samples each.
- This observation emphasizes the ability of the Unyvero panel in
detecting a potential pneumonia pathogen earlier than culture or
very early during an infection.
The investigators reported that Unyvero detected an additional
pathogen from at least one sample collected from 14/27 (52%)
patients. Among these 14 patients, 10 of them had exposure to
antibiotics before the collection of samples for culture and it is
plausible that the exposure to the antibiotics had a negative
influence on the yield of the cultures from these samples. The
authors conclude that “The additional pathogens detected by Unyvero
HPN from a given lower respiratory tract sample could be confirmed
in many instances by culture positivity for the same microorganism
from a previous or a subsequent sample obtained from the same
subject. This observation underscores the ability of the Unyvero
HPN in detecting a potential pneumonia pathogen earlier than
culture and/or very early during infection.”
Faranak Atrzadeh, OpGen’s Chief Marketing and Scientific Affairs
Officer commented: “The findings in this study highlight the
accurate and reliable performance of the Unyvero Pneumonia panel
and its diagnostic and clinical utility in detecting bacterial
pneumonia earlier to enable more prompt and appropriate antibiotic
treatment.”_______________3
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00086-8/fulltext
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 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
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