OpGen Announces Data from Prospective Randomized Controlled Multicenter Clinical Study Using the Unyvero HPN Panel for Hospitalized Patients with Suspicion of Pneumonia
September 15 2021 - 7:30AM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, today announced clinical data from
an investigator-initiated and driven prospective randomized
controlled multicenter study. Data on the Unyvero HPN was presented
at the virtual European Respiratory Society (ERS) conference on
September 7, 2021, and subsequently presented during a webinar held
on September 14, 2021.
The webinar titled “Multiplex Bacterial PCR in
Bronchoalveolar Lavage (BAL) - Does It Impact Inappropriate
Antibiotic Use?” described the study which assessed the clinical
utility and impact of the Unyvero panel in hospitalized adult
patients with suspicion of pneumonia and a clinical indication for
bronchoscopy and at risk for infection with Gram-negative bacteria.
The primary study endpoint was duration of inappropriate antibiotic
therapy.
740 patients were screened, of which 208
eligible patients underwent randomization; 100 patients were
randomized to the intervention group (also referred to as the PCR
group; BAL was analyzed by conventional culture as well as
determination of Gram-negative bacteria using the Unyvero HPN
panel), and 108 patients were randomized to the control group (BAL
was analyzed solely by conventional culture). Within 4 hours after
bronchoscopy Unyvero results were available and shared with the
attending physician treating the patients in the intervention
group.
Pulmonary physician Prof. Daiana Stolz, MD, MPH,
FCCP, FERS, University Hospital Basel, Switzerland, presented a
summary of the study results based on the primary endpoint and
findings from several other measured metrics:
- Inappropriate
antibiotic treatment was significantly shorter in the PCR group –
Unyvero decreased the average duration of inappropriate antibiotic
therapy from 86 hours in the control group to 47 hours in the PCR
intervention group; the low P-value p<0.0001 suggests the
robustness and high statistical significance.
- Inappropriate
antibiotic therapy was reduced by 45.1% in the PCR group.
- Duration of
antibiotic therapy altogether was reduced by 22.5% in the PCR
group.
- Probability of
avoiding inappropriate antibiotic therapy was 3 times higher in the
patient group that was diagnosed by Unyvero.
- Clinical
stability, including reaching clinical stability and/or being
discharged, time to clinical stability or discharge, length of
hospital stay, ICU admission, and 30-day mortality were assessed to
determine if decreasing the amount of antibiotics or reduction in
use of broad-spectrum antibiotics in the intervention group
worsened patient outcomes, and the findings suggested that there
was no significant difference in the two randomized groups.
- In terms of
diagnostic performance, Gram-negative rods in BAL were detected
more commonly by Unyvero PCR than conventional culture – 45
bacteria in 39 patients vs. 32 bacteria in 33 patients,
respectively.
The study concluded that “The results of Unyvero
combined with antibiotic stewardship is efficient and safe in
decreasing time on inappropriate antibiotic therapy in hospitalized
patients with pneumonia at risk for Gram-negative rods.”
Faranak Atrzadeh, OpGen’s Chief Marketing and
Scientific Affairs Officer commented: “This multicenter randomized
interventional study clearly demonstrates the clinical utility and
actionable impact of the Unyvero HPN panel. Unyvero is a rapid and
culture-independent comprehensive diagnostic tool to help with
detection of lower respiratory tract bacterial infections or
co-infections earlier in the hospital journey of severely ill group
of patients in whom rapid and accurate detection is particularly
critical to enable prompt and appropriate targeted antibiotic
therapy to maximize treatment benefit, reducing adverse side
effects and antibiotic resistance. We are excited about this data
and the impact that the Unyvero lower respiratory panels together
with antibiotic stewardship can make in daily clinical practice and
in the management of these patients.”
A recording of this webinar will be available at
OpGen.com.
About Unyvero Lower Respiratory Tract
Panels
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. (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 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 utility of the Unyvero Hospitalized Pneumonia panel
based on the results of studies conducted by independent infectious
disease professionals. 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 fact that we may not effectively use proceeds from our
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:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact:Joe Green Edison
Group jgreen@edisongroup.com
OpGen (NASDAQ:OPGN)
Historical Stock Chart
From Jun 2024 to Jul 2024
OpGen (NASDAQ:OPGN)
Historical Stock Chart
From Jul 2023 to Jul 2024