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OpGen Unyvero IVD Platform Nabs Chinese Regulatory Approval

NEW YORK – OpGen announced on Monday that it has received regulatory approval from the Chinese National Medical Products Administration for its Curetis Unyvero system as an in vitro diagnostics instrument system. 

The submission was filed in February 2019 and included the Unyvero A50 Analyzer, the Unyvero L4 Lysator, and the Unyvero C8 Cockpit. OpGen said in a statement that the NMPA has been "actively engaged" in the review process for the system with its subsidiary Curetis and its Chinese partner Beijing Clear Biotech.

The Unyvero A50 pneumonia cartridge is still under review by the NMPA and if cleared will be the first Unyvero-based diagnostic application for the Chinese market, OpGen said in a statement. The cartridge was also submitted to regulators in February 2019, and timelines for NMPA submissions have been affected by the SARS-CoV-2 pandemic, OpGen said. Commercial launch of the Unyvero platform in China is subject to approval of the pneumonia cartridge, it added.

Curetis and Beijing Clear Biotech have an exclusive multi-year distribution agreement for the Unyvero platform and cartridges in China. Under the agreement, after NMPA approval Beijing Clear will purchase a minimum of 360 Unyvero systems and more than 1.5 million cartridges total over an eight-year exclusivity period. Expected revenue for OpGen as a result of the agreement is approximately $180 million.