LITMUS Detailed plan for submission of biomarkers to the regulatory authorities (EMA and FDA) for qualification

The overarching aim of LITMUS is to develop, robustly validate and advance towards regulatory qualification biomarkers that diagnose, risk stratify and/or monitor NAFLD/NASH progression and fibrosis stage. This will be achieved through a goal-oriented, tri-partite collaboration delivering a definitive and impartial evaluation platform for biomarkers, bringing together: (i) End-users of biomarker technologies (clinicians with expertise in NAFLD and the pharmaceutical industry); (ii) Independent academics with expertise in the evaluation of medical test/biomarker performance; and (iii) Biomarker researchers and developers (academic or commercial).


For deliverable D3.2, we aimed to validate a 7-tier histological staging system for NAFLD-associated fibrosis using digital slides. The EPOS staging system is a 7-tier system for semi-quantitating the extent of fibrosis that has been created and tested by the EPOS Histopathology Group, members of which are included in the LITMUS Histopathology Group – LHG (Bedossa, J Hepatol 2018).

The performance of biomarkers in LITMUS has to be evaluated against well-defined criteria for acceptability. For this purpose,  the context of use/minimally acceptable performance criteria document is prepared by LITMUS partners. These criteria include a definition of the context of use, the appropriate target condition(s), acceptable reference standard, required clinical evidence, and minimum levels of accuracy measurements. The whole document could be accessed here and is meant to be a “living” resource, further modified, if needed, in the course of the LITMUS project and will be periodically updated with additional terms and clarifying information.

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This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 777377. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Visit IMI.

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