Curetis and BGI Group’s wholly-owned subsidiary MGI said they will partner to develop targeted next-generation sequencing (NGS) in vitro diagnostic assays for microbial infection.
Under the collaboration, whose value was not disclosed, Curetis and MGI will develop an assay targeting a panel of pathogens and genetic antibiotic resistance markers. The assay will be applicable to a wide spectrum of native patient sample types, the companies said.
The collaboration will combine Curetis’ Unyvero L4 Lysator with MGI's SP100 Sample Preparation System and MGISeq NGS Sequencers, with the goal of creating an integrated workstation that will enable fully automated lysis, DNA extraction, NGS library preparation and sequencing.
The Unyvero L4 Lysator is designed to process liquid, solid, or highly cellular clinical sample types through a two-step protocol: Patient samples are transferred to the Unyvero sample tube. The tube is sealed with the Unyvero Sample Tube Cap, which contains Proteinase K and a control gene as positive control, then placed into the sample opening of the Lysator.
A Curetis wholly-owned subsidiary, Ares Genetics, will develop an app designed to enable interpretation of NGS data for pathogen identification and genetic antibiotic resistance markers. The app will be developed as a part of the data analysis software.
MGI plans to commercialize the assay in the Greater China market first, with Curetis potentially commercializing the diagnostic in other regions.
MGI has agreed to provide hardware and chemistry integration and develop an automated workflow as well as manufacture the targeted NGS assays. MGI will also oversee validating the assay, and pursuing regulatory approvals.
“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,” Hui Jiang, COO of MGI, said in a statement. “MGI intends to be a first mover in this space and is very pleased to work with the Curetis Group.”
Curetis and Ares Genetics will oversee sample preparation technologies, panel design, and NGS sequencing assay design using Curetis’ Genetic Antibiotic Resistance and Susceptibility (GEAR) database. Ares will also develop a data interpretation app designed to facilitate use of the assay in clinical care by automating the bioinformatics analysis of the NGS data, and supporting the interpretation and visualization of NGS results on pathogens and antibiotic resistance markers.
“This is one of several ways we can capitalize on the tremendous potential of GEAR,” stated Achim Plum, Ph.D., CBO of Curetis and a managing director at Ares Genetics.
He said Ares is in discussions with other potential industry partners. Curetis spun out Ares in April, with the goal of advancing GEAR after acquiring sole commercial rights to the platform and database, as well as GEAR-related patents, patent applications, and related expertise, from the Siemens Technology Accelerator in September 2016 for an undisclosed price.
“Our goal is to create the next generation of molecular microbiology,” added another Curetis managing director, Andreas Posch, Ph.D.
Curetis and MGI said they expect to sign further agreements addressing other aspects of the collaboration—including hardware and chemistry integration, OEM manufacturing and supply, design of panel and assays, and licensing and distribution.
Supporting Ares and BGI Group will be Prof. Andreas Keller, Ph.D., of the Center for Bioinformatics at Saarland University, the leading academic partner in the development of the GEAR: “NGS offers the unique possibility to dissect increasingly complex resistance patterns in microbial pathogens in a single test.”