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Last Updated: 10/20/21

Ancillary/Correlative and Biomarker Studies

Templates for Clinical Assay Development

The following templates have been prepared by groups of experts who are well known in their field of clinical pathology and are intended to document the characteristics of assays as they are to be performed in a CLIA-accredited laboratory. The templates are based on the MISFISHIE principles (Deutsch et al., 2008) and may be included as appendices for Letters of intent (LOIs), concepts or protocols when molecular diagnostics are proposed to be integral markers in clinical trials. If you have any questions or suggestions about the templates, please do not hesitate to contact Dr. Tracy Lively at