Information on antibiotic susceptibility of pathogens is of utmost importance for clinical practice, epidemiology and public health purposes as well as for the development of pharmaceutical products in the infectious disease sector. Ares Genetics therefore has developed a molecular AST that will be marketed under the brand name ARESupa – Universal Pathogenome Assay. It is an expanded version of the NGS-based ARESupa initially launched in August 2019 for the identification of pathogens and resistance genes. The new version of the ARESupa is now capable of also accurately predicting antibiotic susceptibility via AI-powered interpretation of high-throughput DNA sequencing data.
ARESupa is based on whole-genome sequencing of bacterial strains isolated from clinical specimens, combined with data analysis and interpretation powered by ARESdb, Ares Genetics’ unique, proprietary reference database on genetic antimicrobial resistance markers. ARESdb covers genomes of about 40,000 bacterial strains and associated susceptibility data for more than 100 different antibiotics.
Already, Ares Genetics has received commercial orders for more than 1,000 ARESupa tests, an order volume exceeding EUR 500,000. Together with advanced bioinformatics and AI services leveraging ARESdb for the diagnostics and pharma industry, as well as access to certain rights, Ares Genetics has contracted for and received orders amounting to more than EUR 2 million in 2019 to date.
A blinded evaluation study with a leading global IVD player recently demonstrated a predictive performance of the AI-powered ARESupa in line with FDA requirements for over 50 drug/pathogen combinations. Further blinded evaluation studies with leading academic medical centers are anticipated for Q4/2019.
With the early access program gaining momentum, broader commercialization of the AI-powered antibiotic susceptibility test is anticipated to begin in early 2020. The test will be initially offered for non-diagnostic applications in epidemiology, infection control, and outbreak analysis for customers in the public health sector and the pharmaceutical industry. A laboratory-developed test (LDT) on native patient samples for human diagnostic use in indications in which current culture-based diagnostic practice is inherently challenging is planned. Furthermore, Ares Genetics has recently entered into a multi-phase strategic partnership with an undisclosed leading global in vitro diagnostics corporation to jointly develop diagnostic solutions for infectious disease testing based on the ARESupa.
Ares Genetics’ R&D programs for the development of ARESupa are co-funded by non-dilutive public grants provided by the Vienna Business Agency, the Austrian Research Promotion Agency (FFG), and other institutions with a total co-funded volume of up to more than EUR 3 million. In addition to the ARESupa, Ares Genetics provides advanced bioinformatics and AI services to customers in the pharmaceutical industry and in public health, and in September 2019, QIAGEN, in a strategic partnership and under a license from Ares Genetics, launched ARESdb as part of its CLC Microbial Genomics Module for general explorative antibiotic research by the life science community.