OpGen Releases Preliminary Data Demonstrating its Unyvero HPN Panel for Pneumonia Identifies Life-Threatening Bacterial Co-In...
June 09 2020 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, announced today preliminary data
from an investigator initiated collaboration with Karolinska
Institutet, Stockholm, Sweden, to identify bacterial co-infections
in hospitalized patients with COVID-19 pneumonia. The patients in
this cohort had been admitted to the ICU after respiratory
deterioration during hospital stay, and their lower respiratory
tract samples were analyzed with the Unyvero HPN panel.
Preliminary data demonstrates that the
performance of the Unyvero HPN Panel for pneumonia as compared to
bacterial culture is strongly concordant (98.2%) for organism
targets. In 31 out of 35 patient samples that were evaluated,
Unyvero results confirmed all pathogens reported by culture.
Unyvero detected additional pathogens in 7 patients, one of which
was subsequently tested again by microbiological culture 7 days
later and confirmed positive. These results indicate that the
Unyvero system, while not always completely concordant with culture
results, can detect possible pathogens which are missed by culture.
Results obtained by the Unyvero Panel in five hours instead of up
to several days by culture methods provides clinicians with an
early organism differential, including information on antibiotic
resistance markers, allowing earlier treatment decisions and
support for antimicrobial stewardship efforts. Among the 35 lower
respiratory specimens tested to-date, 63% were tracheal aspirate,
34% BAL/mini-BAL, and 3% sputum.
“We are pleased to share preliminary data that
highlights what we already know – when it comes to managing
bacterial co-infections, time is critical! Our Unyvero HPN panel
provides comprehensive diagnostic information to clinicians in just
a few hours, with only minutes of actual hands-on time, ensuring
faster treatment decisions,” said Oliver Schacht, PhD, CEO of
OpGen. “This rapid testing technology is even more important in the
face of a global pandemic when time is of the essence in preventing
global spread. We are encouraged by the preliminary results of our
Unyvero HPN panel in Sweden and look forward to contributing
testing capabilities to additional healthcare facilities around the
world in the future.”
The samples were derived from patients admitted
to ICUs in four acute care hospitals in Sweden – Karolinska
University Hospital, Solna; Karolinska University Hospital,
Huddinge; South General Hospital; Danderyd Hospital, and were taken
from a patient population of SARS CoV-2-positive patients being
admitted to the ICU. Patients were sampled during their hospital
stay for suspected hospital-acquired pneumonia, as they were
already in crowded hospitals and had experienced deterioration and
inevitably requiring ventilators. Of the above-described patient
population, one in four (25%) tested positive for a bacterial
co-infection by microbiology.
“Although secondary bacterial infections are
uncommon upon admission to hospital, these patients are at risk for
hospital-acquired bacterial pneumonia, and the positivity rate is
fairly high,” said Professor and Senior Consultant Physician
Christian Giske, at the Department of Laboratory Medicine,
Karolinska Institutet, Stockholm, Sweden. “That makes receiving
test results in a matter of hours instead of days critically
important. The Unyvero HPN panel empowers clinicians to make
earlier treatment decisions, while supporting antimicrobial
stewardship efforts, to give the best opportunity to quickly treat
and manage bacterial co-infections.”
High-risk COVID-19 patients, especially in
intensive care units and on ventilation, many of whom may be
elderly or have preexisting conditions that compromise their immune
system, are at a higher risk of acquiring bacterial co-infections
that pose severe life-threatening complications. These
co-infections are not always easily determined based on clinical
symptoms alone, and, if they go unnoticed or diagnosis is delayed,
it can lead to dire outcomes including mortality. Within this
preliminary study, the median patient age was 58 years old.
The Unyvero Hospitalized Pneumonia (HPN) panel
detects 21 clinically relevant pathogens and 19 antibiotic
resistance markers in less than five hours directly from native
specimen 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 pneumonia panels that also
include Pneumocystis jirovecii, 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
This press release includes statements regarding
the clinical evaluation of diagnostic tests by subsidiaries of
OpGen. 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, 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 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: Oliver Schacht President and CEO
InvestorRelations@opgen.com
OpGen Press Contact: Matthew Bretzius
FischTank PR matt@fischtankpr.com
OpGen Investor Contact: Joe Green Edison
Group jgreen@edisongroup.com
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