Oxford Nanopore Technologies and leading China-based diagnostic companies collaborate to bring nanopore sequencing-based in-vitro diagnostic tests to China

New collaborations will create a pathway towards real-time clinical metagenomic sequencing and pathogen testing for infectious disease in hospitals and clinics

Oxford Nanopore Technologies (Oxford Nanopore) and leading China-based diagnostic companies, Zheijiang Digena Diagnostic Technology Co. Ltd (Digena) and Wuhan Dgensee Clinical Laboratory Co., Ltd (Dgensee), today announced a series of strategic collaborations that aim to bring nanopore sequencing technology and instruments to the clinical market in China. The strategic collaborations will pave the way for nanopore sequencing to be used in the development of potential future in-vitro diagnostic (IVD) tests for metagenomics, infectious disease, oncology and other conditions for distribution solely in China and in line with local regulatory approval.

These collaborations will extend the benefits of Oxford Nanopore’s platform to the Chinese clinical market, reflecting the intention to apply nanopore sequencing technologies to new IVD solutions in both centralised and decentralised healthcare settings, ranging from small clinics to larger hospitals. Previous collaborations in clinical research and translational applications have demonstrated Oxford Nanopore’s clinical potential by quickly and accurately detecting opportunistic pathogens and infectious diseases.

The initial goal will be to develop IVD tests that can rapidly identify several of the most clinically essential pathogens in the respiratory tract, bloodstream and the central nervous system, including methicillin-resistant Staphylococcus aureus (MRSA). Although the initial scope will encompass infectious disease and metagenomics only, there will be future potential to expand to other diseases if mutually agreed. This may include in human genetics, cancer and other conditions where the unique benefits of Oxford Nanopore sequencing are being demonstrated in a clinical-research setting.

The agreement is a technology collaboration and development. It will supply collaborators with nanopore sequencing products and instruments, expanding access to Oxford Nanopore’s platform advantages in infectious disease, including its rapid turnaround time, scalable device formats for near-sample use, low capital cost and real-time analysis.

Under the agreements, collaborators will drive local development of IVD workflows, application for regulatory approval from China’s National Medical Products Administration authority, manufacturing and commercialisation.

Gordon Sanghera, CEO, Oxford Nanopore Technologies, commented:

“Nanopore sequencing has shown us the potential to quickly and accurately detect opportunistic pathogens and infectious diseases in clinical research settings. We’re excited to advance that work in China, by collaborating with leading diagnostic companies to apply nanopore sequencing technology for the development of highly effective, real-time IVD tests for clinics and hospitals. This collaborationship will be created with a view to future IVD products, and we look forward to bringing the advantages of nanopore sequencing into more healthcare settings in the future and improving lives.”

Yu Zhang, General Manager, Digena commented:

“This signing is not only a major step for the strategic development of Digena Diagnostics in the field of nanopore sequencing, but also the fruitful result of years of in-depth cooperation between the two sides, marking a milestone in the history of Digena Diagnostics. This collaborationship also means that Digena Diagnostics will soon have the independent R&D and production capacity of cutting-edge nanopore sequencers and their reagents, contributing to the localised application of nanopore sequencing technology!”

Aisi Fu, General Manager, Dgensee commented:

“The Dgensee team has worked in the field of nanopore sequencing for many years, witnessed every innovation in the field of nanopore technology, and experienced the rapid development of sequencing data as it has become more accurate, longer and higher throughput, which makes more technical solutions feasible for clinical application. Dgensee’s existing complete solution, after special design and development, can better utilize the powerful technical advantages of nanopore sequencing in clinical applications; at the same time, tailored to the needs of precision medicine, it can provide complete workflow products, from sequencers to accompanying automation devices, software, and reagents, bringing convenient one-stop solutions to clinicians. This strategic cooperation represents another exciting milestone in the development of Dgensee.”