WP5: Clinical practice implementation

Work package 5

Renalytix and LUND University

Fergus Fleming (Renalytix) and Maria Gomez (Lund)

In Work Package 5 PRIME-CKD aims to implement companion diagnostics and personalized medicine in daily clinical practice. The development of the biomarker-test that can be effectively deployed in clinical practice is a primary enabling step in translating the outputs to clinical practice. This can only be done with the direct and early participation of the diagnostics companies who have the processes and expertise to achieve this. We will generate data to demonstrate the robustness of the logistical and laboratory workflow including sample stability, test turnaround time, analytical precision and accuracy and critical raw material supply.

Objectives of this work package:

To identify and address potential barriers to implementation of the response biomarkers across broad patient and provider populations and diverse health systems.
To conduct a Health Technology Assessment to model the health and economic benefits that the implementation of these response biomarkers will deliver, reporting on kidney health outcomes, related health benefits, Quality of Life metrics and economic savings for health systems and insurance payors.
To engage with Competent Authorities and Notified Bodies to define the pathway for CE Marking of the Biomarkertest in accordance with In-Vitro Diagnostics Regulation 2017/746, and to generate the necessary regulatory dossier for one or more diagnostics companies to efficiently complete the final steps to clinical and commercial translation, not just in Europe but globally.

Participants:

Lunds Universitet
Renalytix AI Limited
Universitatsklinikum Erlangen
Alma Mater Studiorum – Universita di Bologna
IRCCS Azienda Ospedaliero – Universitaria di Bologna