E!114787, ENVISAGE, DEVYSER

Purpose and goal:

Objectives of the project was to develop and clinically validate an NGS-based assay and associated software for measurement of donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to monitor graft integrity and identify early risk of rejection when it can still be hampered. The new solution should be a IVD registered product bundle consisting of a ready to use NGS library preparation kit of reagents, optimized protocols and a dedicated software for analysis.

Expected results and effects:

Successful development of two products, a chemistry product (Accept cfDNA) with associated software (Advyser Solid organs) for measurement of donor-derived cell-free DNA (dd-cfDNA) in patients after kidney transplantation. These products can also be used for measuring dd-cfDNA in connection with other solid organ transplants such as heart, lung and liver. IVD registration and the collaboration with Thermo Fisher is expected to result in large market penetration and ultimately help patients.

Approach and implementation:

The project has been carefully planned and followed the company´s quality management system and product development process from concept to final launch where several work packages have been completed. Optimization, verification, validation and registration have been managed by the project team with the support of a reference team with regular reconciliations with the management steering group.