Curetis N.V., a developer of next-level molecular diagnostic solutions, has announced that its wholly-owned subsidiary Ares Genetics GmbH has initiated the development of its ARESupa Universal Pathogenome Assay. The assay for the diagnosis of microbial infections and antimicrobial drug response is based on the Company's proprietary ARES Technology Platform and genetic antimicrobial resistance database ARESdb.
ARESupa is intended to cover nearly any pathogen in a broad array of sample types and to predict antimicrobial drug response to a wide variety of treatment options using a single, uniform laboratory workflow. While planning to launch the test as a laboratory-developed test first, Ares Genetics ultimately aims to seek regulatory approval as an in vitro diagnostic (“IVD”) test, which it will eventually seek to commercialize. For in-house test development and initial commercialization of a laboratory-developed test in Europe, Ares Genetics is in the process of establishing a dedicated R&D and diagnostic service lab at the Vienna BioCenter Campus in Vienna, Austria. Supported by the Austrian Economic Chambers (“WKO”) as a winner of the Austrian “GoSiliconValley” competition earlier this year, Ares Genetics is further exploring fast-track options to launch ARESupa as a laboratory-developed test in the U.S., once development of a first-generation ARESupa has been completed.
Microbial Infections and antibiotic resistance have become a major healthcare challenge, with 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. 1). Ares Genetics seeks to address this challenge with a disruptive approach using high-resolution Next Generation Sequencing (“NGS”) technology in combination with a proprietary, artificial intelligence (“AI”) curated genetic pathogen reference database, ARESdb, to interpret results. Pursuing a partnership-oriented approach, Ares Genetics and Curetishave entered into an agreement with MGI, a BGI Group Company, located in Shenzhen, China, to develop an integrated and fully automated solution for analyzing diverse human samples for microbial infections using NGS. Discussions with other NGS technology providers to utilize their platforms for the deployment of ARESupa are ongoing.
“We are excited to announce the development program for our ARESupa Universal Pathogenome Assay for broadly detecting microbial infections and antibiotic resistances,” said Dr. Andreas Posch, Managing Director of Ares Genetics. “With this assay, we are not only building on ARESdb, which we believe is the world’s most comprehensive database on the genetics of antibiotic resistance, but also leverage our extensive IP portfolio covering antibiotic resistance biomarkers, sample preparation technologies, bioinformatics and artificial intelligence methods. We are therefore convinced that Ares Genetics is well positioned to advance the development of next-generation rapid molecular testing for microbial infections and drug response with the goal to improve patient outcomes and counteract rapidly spreading antibiotic resistance.”
“Founded in 2017, Ares Genetics provides data intelligence for the design and continuous optimization of test panels and interpretation of test results for Curetis’ core business of rapid multiplex PCR testing based on the Unyvero Platform," said Dr. Achim Plum, also Managing Director of Ares Genetics GmbH and CBO of Curetis N.V. "With ARESupa, we intend to take molecular testing for microbial infections to the next level, leveraging the anticipated adoption of NGS technology in clinical diagnostics. With the support of the WKO we are now exploring how we can implement this solution commercially in the U.S. once development of a first-generation ARESupa has been completed.”
With initial seed funding of Ares Genetics provided by Curetis and support from the WKO, Ares Genetics is currently identifying U.S. strategic partners and exploring options for accessing U.S. venture capital funding to accelerate the development of ARESupa and its commercial deployment in the U.S. market.
This initiative is part of Curetis’ ongoing assessment of strategic and tactical financing options to secure appropriate funding and cash for continued operations for at least the next 12 months, a strategy that was previously communicated in the publication of the FY 2017 results on April 30, 2018. While no firm decisions have been taken, the Company is considering making use of the shareholder resolutions authorizing the management board to raise additional capital from institutional investors through the non-preemptive issuance of shares. These resolutions were approved at the AGM on June 21, 2018 for up to 50% of issued capital for strategic financing.