- OpGen (NASDAQ:OPGN) jumps 17% premarket after receiving regulatory approval of the Curetis Unyvero System as an in vitro diagnostics (IVD) instrument system in China.
- A dossier for the review and potential future approval of the pneumonia cartridge was submitted in February 2019, which includes comprehensive data from various clinical trials and regulatory submissions of the Unyvero LRT and LRT BAL products (cleared in U.S.) and the Unyvero HPN cartridge for hospitalized pneumonia patients (CE-IVD marked in Europe).
- OpGen’s subsidiary Curetis and Beijing Clear Biotech are parties to an exclusive multi-year distribution agreement for the Unyvero platform and cartridges in China.