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The combination of the molecular diagnostic companies is structured as an acquisition of Curetis by OpGen. The merged companies will be a based in the US.
Derived from Strategic Transactions, Informa's premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech feature highlights notable technology alliances, R&D partnerships and commercial collaborations. This edition covers industry pacts that were signed in March and April 2019.
FDA granted de novo clearance to Curetis' Unyvero "sample-to-answer" diagnostic system and the Lower Respiratory Tract Infection Application Cartridge, the company announced April 3. Unyvero works with the Unyvero LRT Application Cartridge to provides rapid infectious disease testing directly from aspirate samples in less than five hours. The FDA decision comes a day after the Singapore Health Sciences Authority approved Curetis' Unyvero BCU Cartridge.
German molecular diagnostics company Curetis may have missed its original forecast for a 2017 US launch of its flagship Unyvero infectious disease test platform, but CEO Oliver Schacht is confident that the all-clear from FDA is very close. When this crucial milestone is achieved, the firm will be the first in the US with a molecular diagnostic for lower respiratory tract infections. And the approval could increase Curetis' appeal as an acquisition target for larger diagnostics players.
Diagnostic Imaging Equipment & Supplies
- Molecular Imaging
- Diagnostic Imaging Equipment & Supplies
- Other Names / Subsidiaries
- Ares Genetics GmbH
- Curetis USA Inc
- Curetis N.V.