OpGen Group Company Ares Genetics Demonstrates Feasibility of CLIA-compliant Next Generation Sequencing Workflow for Identifi...
11 August 2020 - 9:30PM
Ares Genetics GmbH (Vienna, Austria; “Ares Genetics”), a subsidiary
of OpGen, Inc. (Nasdaq: OPGN, “OpGen”), announced today the
publication of a peer-reviewed study that demonstrates the
feasibility of a highly accurate and reproducible sample-to-insight
workflow for various clinical microbiology assays including the
molecular identification of bacterial pathogens and their genetic
markers of antibiotic resistance (Ref. 1).
The combined laboratory and bioinformatics
workflow was developed following requirements of the U.S. Clinical
Laboratory Improvement Act (CLIA) for laboratory-developed tests
(LDTs). The bioinformatics analysis workflow leverages the QIAGEN
CLC Microbial Genomics ARESdb Module for detection of antibiotic
resistance (AMR) markers (Ref. 2). Powered by artificial
intelligence, Ares Genetics’ ARESdb is a comprehensive, global and
continuously updated proprietary knowledgebase on AMR markers and
their diagnostic relevance. Under a license from Ares Genetics, the
QIAGEN CLC Microbial Genomics ARESdb Module provides users
information about diagnostic performance parameters for individual
AMR markers at antibiotic compound resolution and thereby addresses
a key limitation of public AMR databases (Ref. 3).
The workflow was validated in a study focused on
particularly challenging and clinically prevalent multi-drug
resistant ESKAPE pathogens (Enterococcus faecium, Staphylococcus
aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas
aeruginosa, Enterobacter cloacae) including the WHO priority 1
pathogens (Ref. 4). In this study, the workflow demonstrated
>99% repeatability, reproducibility, and accuracy. Pathogens
were correctly identified with 100% sensitivity and specificity,
AMR markers with >95% sensitivity and >99% specificity,
respectively.
Dr. Andreas Posch, CEO of Ares Genetics and
corresponding author of the study, commented, “This study
demonstrates that next-generation sequencing in combination with a
standardized bioinformatics workflow and a curated interpretation
database enables a wide array of clinical microbiology assays with
the performance and quality that meet the high standards required
for human diagnostic use. We are very pleased to reach this
important milestone in our development of universal molecular
diagnostic solutions for the timely detection of pathogens and
accurate prediction of antibiotic susceptibility.”
Ares Genetics currently offers NGS-based
clinical microbiology assays for epidemiology, infection control
and research via its AI-powered bioinformatics platform
ares-genetics.cloud under the brand name ARESupa - Universal
Pathogenome Assay. In a recently published multi-center study, Ares
Genetics demonstrated that ares-genetics.cloud can also accurately
predict antibiotic susceptibility based on complex DNA signatures
that are interpreted by combining ARESdb with artificial
intelligence (Ref. 5). The combination of high-resolution NGS and
AI-powered data interpretation can enable accurate as well as
comprehensive molecular antibiotic susceptibility testing and has
the potential to provide information on antibiotic therapy response
much faster than current culture-based approaches.
Dr. Andreas Posch added: “Highly standardized
laboratory workflows like the one we realized in this study, are an
important prerequisite for fast and reliable molecular solutions
for pathogen identification and antibiotic susceptibility
prediction in the clinical routine. They allow locally performed
NGS analysis for expeditious turnaround times and cloud-based
AI-powered data interpretation for clinical decision support. This
enables new business models combining traditional IVD instrument
and reagent business with SaaS business and hence paves the way for
digital diagnostic companies like Ares Genetics.”
Microbial infections and antibiotic resistance
have become major healthcare challenges with rapidly spreading
antimicrobial resistance estimated to have caused 700,000 deaths
globally in 2016, a number that is projected to dramatically
increase to 10 million deaths annually by 2050 if no
countermeasures are taken (Ref. 6). While on July 9th 2020, more
than 20 leading biopharmaceutical companies announced the launch of
the AMR Action Fund aiming to bring two to four new antibiotics to
patients by 2030, a recent white paper by Ares Genetics highlights
the urgent need for novel diagnostic approaches to allow for rapid
identification of causative pathogens and their susceptibility to
available antibiotic options, in order to guide appropriate
treatment of patients while enabling prudent and informed use of
existing or future new antibiotics (Ref. 7).
The studies by Ares Genetics were supported
through funding provided by the Vienna Business Agency and the
Austrian Research Promotion Agency.
References
1) |
Analytical performance validation of next-generation sequencing
based clinical microbiology assays using a k-mer analysis workflow.
Sarah Lepuschitz, Thomas Weinmaier, Katharina Mrazek, Stephan
Beisken, Johannes Weinberger, Andreas E. Posch. 2020. Frontiers in
Microbiology
https://www.frontiersin.org/articles/10.3389/fmicb.2020.01883/full |
2) |
The ARESdb Module
(https://resources.qiagenbioinformatics.com/manuals/clcmgm/current/index.php?manual=ARES_Database.html)
was released 2019 as part of the QIAGEN CLC Microbial Genomics
Module
(https://digitalinsights.qiagen.com/products-overview/discovery-insights-portfolio/analysis-and-visualization/qiagen-clc-microbial-genomics-module/)
within the QIAGEN CLC product line
(https://digitalinsights.qiagen.com/products-overview/discovery-insights-portfolio/qiagen-clc-genomics/) |
3) |
Large-scale assessment of
antimicrobial resistance marker databases for genetic phenotype
prediction: a systematic review. Norhan Mahfouz, Inês
Ferreira, Stephan Beisken, Arndt von
Haeseler, Andreas E. Posch. 2020. Journal of Antimicrobial
Chemotherapy, https://doi.org/10.1093/jac/dkaa257 |
4) |
https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed |
5) |
Species Identification and
Antibiotic Resistance Prediction by Analysis of Whole Genome
Sequence Data Using ARESdb - An Analysis of Isolates from the
Unyvero Lower Respiratory Tract Infection Trial. Ines Ferreira,
Stephan Beisken, Lukas Lueftinger, Thomas Weinmaier, Matthias
Klein, Johannes Bacher, Robin Patel, Arndt von Haeseler and Andreas
E. Posch. 2020. Journal of Clinical Microbiology 58(7):
e00273-20. |
6) |
Tackling Drug-Resistant
Infections Globally: Final Report and Recommendations. The Review
on Antimicrobial Resistance 2016, chaired by Jim O’Neill
https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf |
7) |
https://uploads-ssl.webflow.com/5bbbb630dcca693cb5a8cb21/5f1154c7fa272f68241d147d_FightingAMRWithBetterDiagnostics_AresGenetics_2020.pdf |
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
a validation study of next-generation sequencing based tests
provided by OpGen’s subsidiary, Ares Genetics GmbH. 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 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 Schacht CEO
InvestorRelations@opgen.com
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