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Last Updated: 10/03/14

The Clinical Assay Development Program (CADP)

The Clinical Assay Development Program (CADP) was a three-year program funded through the American Recovery and Reinvestment Act of 2009. Its mission was to further the goal of precision cancer medicine by providing resources to assay developers to validate a research assay to the point where the assay could be used in a clinical trial to guide treatment or better stratify patients and to further the goal. Applications were accepted from academic and commercial assay developers with a prototype assay and an intended clinical use. The program was designed to identify promising molecular tests, assess the needs for further development, and provide services to facilitate optimization of analytical performance and to establish clinical validity so that the clinical utility of the assay could be evaluated in well-designed clinical studies. The services were provided by CLIA-certified laboratories under contract to the program, and were guided by CDP-provided scientific, statistical and Project Management expertise. The CADP also facilitated the acquisition of appropriate human specimens for use in the assay development studies.

The goal of the CADP was to create an efficient process to develop clinical grade diagnostic assays to address clinical needs, including improved prognostication of outcome, co-development of targeted agents and predictive markers. From 2011-2013, twenty-eight applications from 25 applicants were submitted, and 7 assays were accepted to CADP. Three of these projects are still ongoing and 3 (one with 2 assays) have been completed. Although the CADP is no longer accepting applications, the program is being reconfigured to continue pursuing its still-vital mission.

Additional Resources

  • Performance Standards Reporting Requirements for Essential Assays in Clinical Trials
  • Enhancing the Quality and Transparency of Health Research (EQUATOR Network)
  • Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) and the REMARK E&E
  • Consolidated Standards of Reporting Trials (CONSORT)
  • Standards for the Reporting of Diagnostic Accuracy Studies (STARD)
  • Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)
  • MISFISHIE: Minimum Information Specification for in situ Hybridization and Immunohistochemistry Experiments
  • Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP)
  • NCI Experimental Therapeutics Program (NExT)