Roadmap to commercialization and clinical trials: The Members of the TheraMe! Consortium are experienced in the translation of academic technology into marketed products. Our in vitro diagnostic devices will meet the requirements of the markets, clinics and health systems.
Translating academic technology into a marketed product is a challenging endeavor, that we have mastered previously with great success. For example, technology that was initially developed in our labs is now commercially available in form of the Diagenode BioruptorTM (Micro-sonication device for genomics applications; www.diagenode.com/en/p/bioruptor-one-sonication-device) or in routine use at the Antibody Discovery Company Velabs-Therapeutics (www.velabs-therapeutics.com). Based on this experience we are currently addressing all steps necessary for the market launch of our in vitro diagnostics device for routine clinical use:
- On the technology side, we are currently converting a bulky and rather sophisticated experimental setup into a fully integrated, highly robust and user friendly diagnostic benchtop instrument. This includes the use of cutting-edge 3D plastic printing technology for the (scalable) production of disposable microfluidic chips and the replacement of external syringe pumps by reagent reservoirs that are integrated into the microfluidic circuit.
- On the regulatory side, we are currently preparing the performance evaluation of our instrument according to ISO 20916 and ISO 13485 certification of our organization in collaboration with the [Johner Institute GmbH]( https://www.johner-institut.de/). The CE certified product is expected for 2021, but diagnostic laboratories able to self-certify can get access to the technology even earlier.
- On the clinical side, we are planning first trials at Aachen University Hospital for 2021, headed by our consortia member and clinical oncologist Prof. Dr. Thorsten Cramer.