MGI and Curetis to Collaborate on NGS-based Infectious Disease Diagnostics

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MGI and Curetis to Collaborate on NGS-based Infectious Disease Diagnostics

• Broad collaboration to develop a targeted Next-Generation Sequencing assay for microbial infections
• Workflow for native samples integrating MGI and Curetis instrumentation
• Curetis' subsidiary Ares Genetics to provide assay design and data interpretation app

Amsterdam, the Netherlands, and Holzgerlingen, Germany, September 12, 2017; published at 07 am ET -- 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."

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About MGI
MGI (MGI Tech Co., Limited) is a part of BGI Group, one of the world's largest genomics organizations. BGI Group was founded in 1999 with the vision of using genomics to benefit humanity and has been growing exponentially since then. With a focus on research and applications in the healthcare, agriculture, conservation, and environmental fields, BGI Group has a proven track record of innovative, high profile research and operates China National Genome Bank through governmental contracts.

MGI is dedicated to develop, manufacture and distribute instruments, reagents and devices/assays through innovation and collaboration. Since its acquisition of CGI (Complete Genomics Incorporation), MGI adsorbed its technologies quickly and developed a serial of genetic sequencers such as BGISEQ1000, BGISEQ500, and MGISEQ50 etc. MGI's mission is to "Make Great Instrument and Make It Smart" so as to provide in a real time a digitized panoramic view of a living thing at all time and advance life science to service genomics, proteomics and beyond.

About Curetis and Ares Genetics
Founded in 2007, Curetis is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis enable rapid multi-parameter pathogen and antibiotic resistance marker detection in only a few hours, a process that today can take up to days or even weeks with other techniques.

To date, Curetis has raised EUR 44.3 million in an IPO on Euronext Amsterdam and Euronext Brussels and private equity funds of over EUR 63.5 million. Furthermore, Curetis has entered into a debt financing facility with EIB for up to EUR 25 million. The company is based in Holzgerlingen near Stuttgart, Germany. Curetis collaborates with Heraeus Medical, pharmaceutical companies, and has entered into several international distribution agreements covering many countries across Europe, the Middle East and Asia.

In 2017, Curetis established Ares Genetics GmbH, a wholly-owned subsidiary of Curetis GmbH in Vienna, Austria. Ares Genetics is dedicated to maximize the R&D and related scientific and business opportunities of the GEAR assets acquired in 2016 for the entire Curetis Group.

For further information, please visit www.curetis.com.

Curetis' Legal Disclaimer
This document constitutes neither an offer to buy nor to subscribe securities and neither this document nor any part of it should form the basis of any investment decision in Curetis.

The information contained in this press release has been carefully prepared. However, Curetis bears and assumes no liability of whatever kind for the correctness and completeness of the information provided herein. Curetis does not assume an obligation of whatever kind to update or correct information contained in this press release whether as a result of new information, future events or for other reasons.

This press release includes statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "anticipates", "expects", "intends", "may", "will", or "should", and include statements Curetis makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. Curetis' actual results may differ materially from those predicted by the forward-looking statements. Curetis undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

Curetis' Contact Details
Curetis GmbH
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
pr@curetis.com or ir@curetis.com
www.curetis.com - www.unyvero.com

International Media & Investor Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info(@)akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68

U.S. Media & Investor Inquiries
The Ruth Group
Lee Roth
lroth@theruthgroup.com
Tel. +1 646 536 7012

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Curetis
Max-Eyth-Str. 42 Holzgerlingen Germany


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