Elypta Platform for Improved Prognosis of Muscle-Invasive Bladder Cancer

Important results from the project

The project aim was, through a collaboration between Elypta, Mediteq and Lund University, to execute pre-marketing activities for the commercialization of a new test for muscle-invasive bladder cancer prognosis (MIBC), based on Elypta’s metabolism-based liquid biopsy platform which leverages blood/urine glycosaminoglycans as biomarkers. The objectives were fulfilled: clinical evidence was generated through clinical study AURORAX-0093A, regulatory and reimbursement strategies were completed and a technical documentation package for submission was prepared.

Expected long term effects

The project results were positive: pilot clinical data provided preliminary evidence for the Elypta MIBC prognosis test performance; the regulatory pathway to commercialization foresees no critical obstacles and the reimbursement investigation concluded there is reimbursement potential for the Elypta test. The project has made clear that a test for MIBC prognosis like Elypta’s has the potential to significantly improve the health outcomes and result in cost-efficiencies in healthcare.

Approach and implementation

The project was executed by Elypta, developers of the novel MIBC prognosis test, Mediteq, providing competence in medical device regulation, and Lund University, providing urology expertise and end-user feedback. With complementary expertise, the partners completed three parallel Working Packages: WP1 management of the overall project; WP2- execution of the AUR93A study for clinical evidence generation; WP3 mapping of the regulatory and reimbursement strategy to support the Platform’s path to commercialization.