3D-SELECT UPPSALA UNIVERSITY

Important results from the project

Oncodia launched two CE for IVD products, VARify® and ALTOmate®. Facilitated by our partners, we fully fulfilled the goals of complete technical development, commercial launch of products and regulatory proficiency in medical devices certification and maintenance in the IVDD and IVDR frameworks. On top the company grew from 0,27 FTE to 5 FTE during these years. The Eurostars grant, under the 3D-SELECT consortium was a needed catalyst in our success story.

Expected long term effects

Uppsala University and Oncodia are associated with a new European network of scientists and clinical specialists in pathology and oncology, with access to samples, data, and expertise in cancer care. There is a partnership with other European companies, to provide a common diagnostics platform for early prediction of treatment outcomes, 3D-SELECT. Importantly, the established references in the participating countries can benefit each of the partners and is already a market opportunity.

Approach and implementation

Despite the slow rate of patient recruitment and sample acquisition, heavily influenced by the COVID-19 outbreak, the scientific outcomes and the commercial success is evident for the participants. We envision that each site can launch its own products or services to support the 3D-SELECT concept. Driving the regulatory certification through IVDR, shall be initially restricted in the respective EU regions and supported by the private capital of the commercial partners. The individual modules can be assembled in a common service, if required by the final 3D-SELECT implementation.