主要判断标准在于biomaker 是否是 pivotal。

The major key criteria behind the appropriate level of validation for a biomarker assay is the knowledge of whether or not this biomarker will become “pivotal” from a regulatory point of view in the pharmacokinetic (PK), safety, or efficacy section of the submission. In other words, if the biomarker itself becomes the efficacy measure for the Phase III trial, then it needs to be fully GLP validated. If the biomarker is only used as a marker of efficacy or safety to better understand the optimal dosing regimen, then it does not need to be GLP validated. The FDA and EMEA are now meeting jointly to discuss the clinical validation of biomarkers. However, the need to use a biomarker that the FDA has deemed to be clinically validated is only needed if the biomarker will become pivotal. POC studies often include analysis of biomarkers that are used for research purposes, so their measure does not require a bioanalytical validation or for the FDA to consider them clinically validated.