OpGen Group Company Ares Genetics Demonstrates Feasibility of CLIA-compliant Next Generation Sequencing Workflow for Identification of Bacterial Pathogens and Antibiotic Resistance Markers

Accurate identification of antibiotic resistance markers based on the ARESdb QIAGEN CLC Module leveraging Ares Genetics’ proprietary antibiotic resistance database

Pathogens correctly identified with 100% sensitivity and specificity, antibiotic resistance markers with >95% sensitivity and >99% specificity, respectively

Study paves the way for routine clinical diagnostic application of next-generation sequencing (NGS) in timely as well as accurate infectious disease testing and drug susceptibility prediction

VIENNA, Austria, and GAITHERSBURG, Md., Aug. 11, 2020 (GLOBE NEWSWIRE) — 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.