OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, today announced prospective
clinical data on the Unyvero LRT BAL presented during a webinar
held on June 29, 2021, and data presented at the virtual World
Microbe Forum, June 20-24, 2021.
The webinar titled “One Academic Medical
Center's Experience with the Unyvero Multiplex Platform for Testing
Bronchoalveolar Lavage Fluids: Analytical and Clinical Assessment”
studied patients in the intensive care unit (ICU) for whom
bronchoalveolar lavage (BAL) specimen was ordered for diagnostic
purpose and prospectively evaluated with the Unyvero LRT BAL panel
in conjunction with quantitative bacterial culture and
antimicrobial susceptibility testing (AST). Results from the
Unyvero panel were communicated to the team of primary providers
and the infectious disease pharmacist, who is a member of the
antimicrobial stewardship program (ASP). The clinical impact of the
Unyvero results on antibiotic stewardship and patient management
were discussed and acted upon in real-time, enabling earlier
adjustment of antimicrobial therapy in 53% of cases. De-escalation
occurred in 33% of patients, and 20% of patients had an escalation.
Changes in therapy occurred significantly faster with the Unyvero
LRT BAL, on average 21 hours faster, compared to when conventional
AST result was available.
Presented jointly by Dr. James W. Snyder,
Professor of Pathology and Laboratory Medicine, University of
Louisville, and Dr. Wes Hoffmann, Infectious Disease Pharmacist,
University of Louisville Health System, Louisville, KY, they
reported Unyvero results had 99.2% overall concordance for organism
targets and 90% agreement for resistance genes when compared to
bacterial quantitative culture and phenotypic susceptibility
testing. In addition to the excellent concordance, Unyvero had more
detections for organisms that are known causative agents of
pneumonia such as S. aureus, E. coli, K. pneumoniae, H.
influenzae and Citrobacter that were missed by culture.
Based on real-time clinical use of the Unyvero
LRT BAL panel, they determined that the panel’s S. aureus NPV is
97%, giving a solid indication that MRSA is not present causing the
respiratory infection. By being able to de-escalate MRSA therapy,
there are several major benefits, notably the mitigation of the
potential for adverse vancomycin-induced nephrotoxicity and
reducing the cost of drug as well as the cost of managing the
administration of vancomycin. Similarly, they found the Unyvero
panel Pseudomonas and Acinetobacter both have NPV of 98%, and often
times it is unlikely that antipseudomonal therapy will help in
those settings particularly extremely broad-spectrum agents like
carbapenems. They concluded: “The negative predictive values (NPV)
of the Unyvero LRT BAL panel can be extremely useful in reducing
excess exposure to unnecessary antimicrobials, particular MRSA
therapy and carbapenem and antipseudomonal therapy, and the panel
can provide rapid and actionable results particularly if used in
conjunction with an active antimicrobial stewardship program.” A
recording of this webinar can be accessed at OpGen.com.
At the World Microbe Forum 2021, an iposter
titled “Clinical Evaluation of a Multiplex Molecular Diagnostic
Lower Respiratory Tract Panel for Bronchoalveolar Lavage Specimens”
by Drew Bell et al. of Indiana University School of Medicine,
Indianapolis, IN, reported that the Unyvero LRT BAL provided a
basis for appropriate escalation and de-escalation of antibiotic
therapies in 42% of cases, reducing time to appropriate therapy by
31 hours. They evaluated the efficacy and potential clinical impact
of the Unyvero LRT BAL panel compared to conventional
microbiological methods in 70 patients, including:
Community-Acquired Pneumonia (CAP, 30), Hospital-Acquired Pneumonia
(HAP, 15), Ventilator-Associated Pneumonia (VAP, 8), Aspiration
Pneumonia (1), as well as non-pneumonia (16) patients. Analysis of
retrospective chart reviews performed on these patients revealed
that, based on conventional microbiological results, 38% were
undertreated, 20% were overtreated, while only 23% were
appropriately treated and 19% were appropriate without antibiotic
treatment. The Unyvero LRT BAL results would have provided a basis
to change antibiotic therapies to a more appropriate regimen
faster, with 29% of cases having cause of escalation of therapy,
13% of cases having cause for de-escalation, and in 27% of cases
antibiotic treatment would not have been indicated (vs. 19% based
on culture results) which would have reduced unnecessary
antibiotics in 8% of cases. Particularly of interest to this study
were the inclusion of 9 patients that were determined to have
Pneumocystis jirovecii pneumonia (PJI) via microscopy, and for whom
Unyvero LRT BAL results demonstrated complete agreement with the
diagnosis of PJP. In addition, Unyvero detected Pneumocystis
jirovecii in a patient that was not conventionally diagnosed with
PJP; however, further chart review demonstrated that the patient
was newly diagnosed with HIV and was treated empirically with
trimethoprim-sulfamethoxazole. It is important to note that
Pneumocystis jirovecii is a non-culturable fungus, and in the
absence of PCR testing, PJP diagnosis relies on microscopic
examination of trophic forms or cysts, which is laborious and
insensitive. The Unyvero LRT BAL panel includes rapid and reliable
detection of Pneumocystis jirovecii in just 5 hours with only about
2 minutes of hands-on time.
During the Rapid Fire session of the World
Microbe Forum 2021, Dr. Cory Hale, Infectious Disease Clinical
Pharmacist, Penn State Health Milton S. Hershey Medical Center,
Hershey, PA, presented on Unyvero LRT, titled “Antimicrobial
Stewardship Opportunities Using Results from a Multiplex Molecular
Lower Respiratory Tract Panel as Compared to Conventional Culture.”
Their data characterized the potential impact of Unyvero LRT on
antibiotic therapy in patients being treated for pneumonia and
retrospective chart reviews were performed in 92 of these patients
(39 tracheal aspirates, 53 sputum specimens), including 51 (55.4%)
critically ill ICU patients and 39 (42.4%) pediatric patients. They
reported complete agreement between Unyvero LRT and culture results
in 50% of cases, and in 45.7% of cases Unyvero yielded more
information than culture, with Stenotrophomonas maltophilia,
Pseudomonas aeruginosa and Staphylococcus aureus among the top 3
most frequently detected pathogens by Unyvero. Overall, antibiotic
changes would potentially have been made in 31 (33.7%) of the
patients based on the Unyvero panel results (13.0% de-escalations,
23.9% escalation of therapy). They concluded that “Decreased
turnaround time of results provided by the Unyvero LRT could
provide targeted coverage sooner and should be coupled with an
antibiotic stewardship program to ensure antibiotic coverage is
optimal and necessary.”
In addition, two posters on the Acuitas AMR Gene
Panel for Isolates were presented at this conference by Wadsworth
Center, New York State Department of Health (NYSDOH), Albany, NY,
and their participating sites. Titled “Combating Antimicrobial
Resistance in New York State with Public Health Partnerships,” this
poster highlighted the collaboration project between the Wadsworth
Center (WC) and OpGen, Inc. as part of the New York State Life
Sciences Initiative, to demonstrate the benefit of a rapid
molecular diagnostic assay in identifying relatedness of
antimicrobial resistant (AR) organisms indicative of outbreaks or
transmission. To assess this, all carbapenemase-producing
carbapenem-resistant organisms (CP-CRO) culture isolates were run
on the Acuitas AMR Gene Panel for Isolates and results were
compared to whole-genome sequencing (WGS) performed at WC. The
project included three pilot sites, Northwell Health, NYU Langone
and Mount Sinai who submitted CRO isolates. The results
demonstrated that the Acuitas AMR Gene Panel in conjunction with
the Acuitas Lighthouse Software is a promising new test that may be
used as a front-line tool in clinical settings for cluster
detection and implementation of infection control. The second
poster, titled “Comparative Analysis of a Carbapenemase-producing
Klebsiella pneumoniae Outbreak in a New York State Healthcare
Facility using Multiple Typing Methods” investigated a large
outbreak of carbapenemase-producing carbapenem-resistant
Enterobacteriaceae (CP-CRE) at a healthcare facility detected
through the AR Laboratory Network using multiple molecular
epidemiology typing methods, and concluded that the Acuitas AMR
Gene Panel produced highly concordant results with WGS, and that
these findings can be used to improve infection control practices
in this and other facilities.
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 studies conducted by independent infectious disease
professionals presented at a recent webinar and at the 2021 World
Microbe Forum on OpGen’s Unyvero LRT BAL panel as well as the
Acuitas AMR Gene Panel for Isolates (RUO) and their 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 November 2020
private placement, February 2021 Registered Direct and March 2021
warrant exercise and exchange, 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:Joe
GreenEdison Groupjgreen@edisongroup.com
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