Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, and MGI, a fully-owned subsidiary of BGI Group, one of the world's leading genome sequencing centers headquartered in Shenzhen, Guangdong, P. R. China, today announced that they have signed a Memorandum of Understanding (MoU) for a broad collaboration to develop targeted Next-Generation Sequencing (NGS) IVD assays for microbial infections.
The assay will target a comprehensive panel of pathogens and genetic antibiotic resistance markers and will be applicable to a wide spectrum of native patient sample types. The intended laboratory workflow will combine the Unyvero L4 Lysator by Curetis with MGI's SP100 Sample Preparation System and MGISeq NGS Sequencers to allow fully automated lysis, DNA extraction, NGS library preparation and sequencing or an integrated workstation. The resulting NGS data will be interpreted for pathogen identification and genetic antibiotic resistance markers by an app as a part of the data analysis software. The app will be developed by Ares Genetics GmbH, a wholly-owned subsidiary of Curetis GmbH based in Vienna, Austria. The assay will be commercialized by MGI in Greater China first and potentially by Curetis in other geographies. Financial details were not disclosed.
Under the terms of the agreement, MGI will provide hardware and chemistry integration and develop an automated workflow as well as manufacture the targeted NGS assays. MGI will also be in charge of validating the assay and seeking regulatory approval as needed. Curetis and Ares Genetics will provide expertise in sample preparation technologies, panel design and NGS sequencing assay design using its GEAR GEnetic Antibiotic Resistance and Susceptibility database. Ares will also develop a data interpretation application that automates the bioinformatics analysis of the NGS data and supports the interpretation and visualization of NGS results on pathogens and antibiotic resistance markers detected by the assay to facilitate the deployment of the assay in the clinical routine. Ares and BGI Group will be supported by Prof. Dr. Andreas Keller from the Center for Bioinformatics at Saarland University, the leading academic partner in the development of the GEAR.
The partners entered into a first collaboration agreement under the MoU to assess the feasibility of using MGISeq sequencing data with the GEAR database. Curetis and MGI expect to enter into further agreements to cover other aspects of the collaboration, e.g. hardware and chemistry integration, OEM manufacturing and supply, design of panel and assays, and licensing and distribution.
"The planned collaboration is an excellent example for leveraging Curetis' molecular microbiology expertise and its solutions in combination with GEAR," said Dr. Achim Plum, CBO of Curetis and a Managing Director at Ares Genetics. "The synergies with MGI will turn us into a first mover in NGS-based IVDs for severe microbial infections." He added that Ares is also in discussions with other industry players. "This is one of several ways we can capitalize on the tremendous potential of GEAR."
“NGS offers the unique possibility to dissect increasingly complex resistance patterns in microbial pathogens in a single test. However, this requires smart data interpretation and clinical decision support. BGI Group sequencing technology combined with the GEAR database allows the translation of NGS technology into meaningful diagnostic applications for complex microbial infections. Therefore, I am excited to support both companies in this endeavor,” commented Prof. Dr. Keller.
"NGS-based diagnostics of pathogens and resistances is becoming more and more feasible," said Dr. Andreas Posch, also a Managing Director at Ares Genetics. "To this end, panel design and data interpretation are key. That's where the tremendous data collection of GEAR and the BioIT expertise of Ares Genetics comes in. Our goal is to create the next generation of molecular microbiology."
"Today, NGS is dominating the sequencing space in genomic research," said Dr. Hui Jiang, Chief Operation Officer of MGI, "But it is already entering clinical practice, e.g. in prenatal screening and cancer diagnostics. While it already is a key technology in infectious disease research today, the unique features of NGS, the technological advances, the workflow integration and automation as well as the affordability make NGS more and more applicable to the clinical diagnostics of infectious diseases. MGI intends to be a first mover in this space
and is very pleased to work with the Curetis Group."