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 results from
the highly attended webinar titled “Pneumonia Diagnosis: Bacterial
Superinfection in COVID-19 Patients”, where two infectious disease
experts presented their independent study results from the Unyvero
Hospitalized Pneumonia (HPN) and Unyvero Lower Respiratory (LRT
BAL) panels, respectively. Their studies demonstrated that
syndromic testing of lower respiratory specimens with Unyvero HPN
and LRT BAL panels can improve patient care and time to appropriate
targeted antibiotic therapy in COVID-19 pneumonia patients, as well
as in a non-COVID-19 population with suspicion of pneumonia,
including Pneumocystis jirovecii Pneumonia (PJP).
Professor and Senior Consultant Physician
Christian Giske (MD, PhD), at the Department of Laboratory
Medicine, Karolinska Institutet, Stockholm, Sweden, discussed
“Diagnosing bacterial pneumonia in COVID-19” in his presentation,
and highlighted several important findings from his study and key
advantages of the Unyvero HPN panel compared with conventional
bacterial culture:
- Unyvero demonstrated higher
diagnostic yield (25.3% more detections) than bacterial culture,
including several key pathogens of concern such as S. aureus, P.
aeruginosa, S. marcescens, H. influenzae, K. oxytoca, S.
maltophilia. Notably, S. maltophilia was called out as an important
target on the Unyvero panel because of its intrinsic resistance
against many of the standard antibiotics.
- Analysis of chart reviews of
patients that had multiple lower respiratory cultures ordered
during the course of their hospital stay revealed two clinically
important cohorts:
- In Group 1, culture and Unyvero HPN
results were 100% concordant on the first and all subsequent
samples that had been ordered. The findings in this cohort
demonstrated that Unyvero HPN would enable significantly more rapid
detection of pathogens not covered by empiric therapy due to
intrinsic resistance, i.e. S. maltophilia, or multidrug resistant
organisms (MDROs), i.e. carbapenem-producers, within 5 hours vs.
2.5 days by culture.
- In Group 2, Unyvero HPN detected
bacterial pathogens up to 7 days earlier in patient samples that
were initially negative by culture but subsequent cultures ordered
during hospital stay were confirmed as positive for the same
pathogen at a much later stage. As a consequence of lack of finding
any microbial etiology by culture, this group of patients were
exposed to longer duration of empirical antibiotic treatment. This
group also had longer hospital length of stay (LOS), longer ICU LOS
and longer VAP duration, which could have been shorter if
antibiotics could have been tailored and targeted earlier. “The
potential impact of Unyvero HPN in this group could be
significantly greater than in Group 1,” stated Prof. Giske, as he
presented several clinical cases of patients with ongoing infection
where culture exhibited intermittent detection of pathogen(s)
impacted by antibiotics across serial sampling while Unyvero HPN
demonstrated consistent and steady detection of these pathogen(s).
Prof. Giske pointed out that similar findings were reported1 by
Pickens et al. where chart reviews were performed on 4
culture-negative Acinetobacter cases that Unyvero had reported
positive for Acinetobacter, and subsequent cultures grew
Acinetobacter. In these cases, empiric therapy did not adequately
cover for Acinetobacter and all four patients died.
Prof. Giske concluded his presentation with the
following remarks: 1) distinguishing those COVID-19 ICU patients
with bacterial superinfection early and accurately is crucial for
patient management and antibiotic stewardship; 2) Excellent NPV of
99.8% allows for a reduction in unnecessary antibiotics use; 3)
Unyvero reduces diagnostic turnaround time to about 5 hours (vs. an
average of 2.5 days for final culture results), and it can easily
fit into a 24/7 lab workflow; and 4) Unyvero provides clinicians
earlier data to inform antimicrobial decisions, especially in
critically ill COVID-19 patients.
The second presentation focused on a number of
clinical cases from the Unyvero LRT BAL study that exemplify the
performance characteristics and potential clinical impact of this
Unyvero panel in pneumonia diagnostic algorithms, presented by Drew
Bell (PhD), Medical and Public Health Microbiology Fellow at
Indiana University School of Medicine, Indianapolis, IN. The
patient population in this study (n=63) included pneumonia:
Community-Acquired Pneumonia (CAP, 27), Hospital-Acquired Pneumonia
(HAP, 14), Ventilator-Associated Pneumonia (VAP, 8), Aspiration
Pneumonia (1), as well as non-pneumonia (13) patients. Results of
Unyvero LRT BAL were compared to conventional microbiological
methods including bacterial culture for pathogen identification and
antimicrobial susceptibility testing, as well as microscopic
examination for PJP.
Analysis of retrospective chart reviews
performed on these patients revealed that, based on conventional
microbiological results, 41% were undertreated, 19% were
overtreated, while only 25% were appropriately treated and 16% were
appropriate without antibiotic treatment. In contrast, the study
demonstrated that using the Unyvero LRT BAL panel would have
enabled prompt and appropriate targeted antibiotic therapy in 41.3%
of cases, including escalations (i.e. detection of S. aureus and
mecA 11 to 18 hours earlier than culture), and de-escalations (i.e.
detection of M. catarrhalis, which would have enabled
de-escalation from piperacillin/tazobactam and azithromycin to
amoxicillin clavulanate in just 5 hours), and reduced time to
appropriate therapy by 25.7 hours.
This presentation also called out the fact 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. Clinical cases were presented which demonstrated the
rapid and reliable detection of Pneumocystis jirovecii using the
Unyvero LRT BAL panel in just 5 hours with only about 2 minutes of
hands-on time.
Key comments and concluding remarks from Dr.
Bell were that, “Implementing rapid molecular testing for lower
respiratory specimen assessment algorithms can lead to faster
identification and decrease time to appropriate escalation and
de-escalation of antibiotic therapies. The Unyvero LRT BAL panel
includes fastidious organisms, as well as organisms that are
difficult to culture or completely unculturable, and the minimal
amount of hands-on time is a big benefit.” In addition, he noted
that “the Unyvero LRT BAL panel provides a notable improvement in
diagnosis of PJP.”
A recording of this webinar can be accessed at
OpGen.com.
About Unyvero HPN and LRT
BAL
The Unyvero Hospitalized Pneumonia (HPN) panel
detects 21 clinically relevant pathogens and 19 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 studies conducted by independent infectious disease
professionals presented at a recent webinar on OpGen’s Unyvero HPN
and Unyvero LRT BAL panels 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, February 2021, and March
2021 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://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A7770
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