Elypta Platform for Improved Prognosis of Muscle-Invasive Bladder Cancer

Purpose and goal:

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 results and 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.