Aurora Life Sciences
| Reference number | |
| Coordinator | CHALMERS TEKNISKA HÖGSKOLA AKTIEBOLAG - Biology and Biological Engineering -Food and Nutrition Science |
| Funding from Vinnova | SEK 664 510 |
| Project duration | June 2016 - May 2017 |
| Status | Completed |
Purpose and goal
In this project, we sought A) to verify with 2 dedicated clinical trials if a recently discovered glycosaminoglycan (GAG) blood and urine test for ccRCC diagnostics could address two critical clinical problems and B) to delineate a path to commercialization for the test. We gladly report significant progress in both aspects that induced to incorporate a company called Elypta AB.
Expected results and effects
The trials were approved and started to enroll patients and, despite completion was planned for 2018, preliminary analyses are in line with the expected aims of the trials. The path to commercialization was tested with industry stakeholders, and regulatory, IP, and health economics consultants, evidencing a feasible business model to accelerate future adoption of the test.
Planned approach and implementation
The clinical studies were designed and conducted together with the Department of Urology and Oncology at Sahlgrenska University Hospital in Göteborg. Patient enrollment was started in June 2016 and is expected to reach the target sample size in March 2018. Interim analyses was started in March 2017 and to be completed in July 2017. The business model was conceptualized through interviews among 27 industry stakeholders in EU and US. Consultants from one regulatory firm, one IP firm, and two health economics firms reported on the feasibility of different aspects of the business model.