Update to the European Bioanalysis Forum Recommendation on Biomarkers Assays; Bringing Context of Use Into Practice

Abstract

In 2012, the European Bioanalysis Forum published a recommendation on biomarker method development and the bioanalysis of biomarkers in support of drug development. Since then, there has been significant discussion on how to bring the topic of context of use of biomarker assays to the forefront so that the purpose of the assay, the use of the data and the decisions being made with the data are well defined and clearly understood, not just by the bioanalytical scientist, but across all stakeholders. Therefore, it is imperative that discussions between the bioanalytical laboratory and the end users of the data happen early (and regularly) in the drug development process to enable the right assays to be developed and appropriately validated to generate the correct data and allow suitable decisions to be made. This updated refinement to the previous European Bioanalysis Forum recommendation will highlight the items to consider when discussing context of use for biomarker assay development and validation, thus enabling the correct conversations to occur and the move away from the misapplication of PK assay validation criteria to biomarker assays.

Assessing biomarker stability and assay performance parameters for the use of biomarkers in mental disorders; A study of early stage biomarker assay method development

“…The development and validation of a biomarker assay should follow the context of use principle and be developed as t for purpose. Structural pillars for this development include assay parameters such as parallelism, selectivity, sensitivity and stability (Goodman et al, 2020;Piccoli and Michael Sauer, 2019). Based on data obtained for these parameters assay acceptance criteria can be set which can be different between various biomarker assays (Goodman et al, 2020).…”

“…Structural pillars for this development include assay parameters such as parallelism, selectivity, sensitivity and stability (Goodman et al, 2020;Piccoli and Michael Sauer, 2019). Based on data obtained for these parameters assay acceptance criteria can be set which can be different between various biomarker assays (Goodman et al, 2020). These factors do not need to be determined within an early phase but are considered imperative along the way of biomarker assay development to assure that the method is t for purpose.…”

Assessing Biomarker Stability and Assay Performance Parameters for the Use of Biomarkers in Mental Disorders; A Study of Early Stage Biomarker Assay Method Development

“…The development and validation of a biomarker assay should follow the context of use principle and be developed as t for purpose. Structural pillars for this development include assay parameters such as parallelism, selectivity, sensitivity and stability [30,31]. Based on data obtained for these parameters assay acceptance criteria can be set which can be different between various biomarker assays [30].…”

“…Structural pillars for this development include assay parameters such as parallelism, selectivity, sensitivity and stability [30,31]. Based on data obtained for these parameters assay acceptance criteria can be set which can be different between various biomarker assays [30]. These factors do not need to be determined within an early phase but are considered imperative along the way of biomarker assay development to assure that the method is t for purpose.…”

Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report

“…Other categories that were highlighted by Dr. Amaravadi include the stage of development the biomarker will be used in and how the biomarker will be used (safety, diagnostic, etc.). Goodman et al discuss in-depth various aspects to consider when establishing the COU and provide a broad set of questions a biomarker scientist should address when defining the COU (Goodman et al 2020).…”