Table 2.

Biomarkers and proposed level of stringency of the assay during drug development

PhaseEndpointCertification
IPrimary 
 ToxicityCLIA/GCLP
Secondary 
 RRCLIA/GCLP
 PharmacokineticsCLIA/GCLP
 PharmacodynamicsCLIA/GCLP
Exploratory 
 Enrichment biomarkersNoa
IB/IIPrimary 
 RR/SurvivalCLIA/GCLP
Secondary 
 Predictive biomarker relationship with primary endpointCLIA/GCLP
Exploratory 
 New candidate biomarkersNoa
IIIPrimary 
 Biomarker-selected survivalCLIA/GCLP
Secondary 
 New proposed biomarkers in phase IICLIA/GCLP
  • a Local standards apply.