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Curetis' Partnership With BGI Marks Its Entry Into Sequencing-Based Diagnostics

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SAN FRANCISCO (GenomeWeb) – Earlier this week Curetis struck up a partnership with BGI subsidiary MGI Tech to develop in vitro diagnostics for microbial infections, which Curetis said is its first foray into the next-generation sequencing space and will offer an opportunity to leverage its database of genetic and antibiotic resistance markers.

Curetis launched subsidiary Ares in April in order to have a dedicated entity to pursue business opportunities surrounding its Genetic Antibiotic Resistance and Susceptibility (GEAR) database.

The deal with MGI Tech is one such opportunity. Under the terms of the deal, MGI Tech will be responsible for the engineering and hardware sides of developing diagnostics, including the sequencing instrument and reagents. Curetis will focus on much of the front-end steps, such as going from a patient sample to isolated genomic DNA, and MGI Tech will then integrate those steps with its sequencing instrument, MGISeq.

According to a BGI spokesperson, the Chinese genomics company launched MGI Tech in April 2016 to focus on R&D as well as manufacturing and distribution of BGI's genomic instruments and reagents. The subsidiary is based in Shenzhen, China.

The NGS instrument, MGISeq is based on the DNA nanoball sequencing technology that currently powers the BGISEQ-500 and BGISEQ-50 instruments, which was originally developed by Complete Genomics. The spokesperson declined to provide additional details about MGISeq, including how or whether MGISeq differs from the BGISEQ family of instruments.

In addition, Curetis plans to make use of the GEAR database via Ares. It will tap into the database to figure out which genetic and antibiotic resistance markers to include in a diagnostic test. Curetis will also be responsible for the bioinformatics and interpretation portions of the tests, and as part of that plans to develop an app for data interpretation.

Achim Plum, chief business officer of Curetis, said that the two companies would be in a "feasibility phase" for the first few months of the partnership, working to combine the MGI sequencing platform with the GEAR database and to link its Unyvero Lysator, a sample prep instrument that lyses pathogens in the patient sample, to the MGI instruments for sample preparation and sequencing.

As part of the initial feasibility phase, the company will work with Andreas Keller, who chairs the clinical bioinformatics group at Saarland University in Germany. Keller's group previously collaborated with Siemens to develop the GEAR database and has an ongoing partnership with Ares to further develop the database. Keller's group has also worked with BGI to sequence microRNA on the BGISEQ-500 instrument.

Plum said that after the feasibility phase, the company would have a better idea about a timeline to its first product. In addition, he said, the companies are still figuring out the types of tests and how comprehensive the tests will be. The focus will be on serious microbial infections and will be geared for a hospital setting — including both hospital-acquired and community infections. 

Tests will be for the most prominent infections and will cover the major indications, said Plum. The NGS assays will "initially be used for complex cases that can't be resolved by other methods," he added. "So, that requires that the assays be rather broad."

The assays will initially be marketed in China, and MGI Tech will be responsible for obtaining regulatory approval from the China Food and Drug Administration. One step to validate the assays for the Chinese population will be to ensure that the genetic and antibiotic resistance markers included in the GEAR database are relevant for the Chinese population. "From initial studies, it seems that the major resistance markers will be universal, but that's something we'll have to verify," Andreas Posch, Curetis' director of GEAR and bio-IT, said.

"The design of the panels and scope of the markers have yet to be specified," Posch said. "We may start with one set of resistance markers but add to it." And, ultimately, an NGS IVD panel could potentially result "in a single metagenomic direct sequencing test covering all pathogens and resistance markers," he added.

While the first market for the assays will be China, Plum said that there is the possibility of expanding the BGI partnership to other countries where BGI has a presence. In addition, Curetis is exploring the option of forging similar partnerships with other companies in other countries to develop NGS-based diagnostics using the GEAR database.