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Last Updated: 07/21/14

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 (1) and may be downloaded by any investigators who may wish to use them as they develop assays for either discovery research or use in clinical trials. These templates 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. Jessup at jessupj@mail.nih.gov.

1) Deutsch EW et al. Minimum information specification for in situ hybridization and immunohistochemistry experiments (MISFISHIE).  Nat Biotechnol. 2008 Mar;26(3):305-12.