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U.S. National Institutes of Health

Do you need:

  • Advice on further development of a cancer diagnostics assay?
  • Assay optimization?
  • Design or implementation of assay controls, assay standards or assay calibrators?
  • Determination of assay analytical parameters such as specificity, sensitivity, repeatability, precision and assay limits?
  • Annotated specimen sets for assay validation?
  • Platform migration?
  • Standard operating procedures for a “locked down” assay?
  • Statistical consultation and support?
  • Partners to complete development of a cancer diagnostic assay?
  • Other resources to support assay development?

The Clinical Assay Development Program can help.

NCI/DCTD provides a variety of services to the Cancer research community, including screening and provision of banked materials. Any services or materials that NCI may provide to applicants will be subject to review at any time and may not be available for a variety of reasons, including but not limited to: the availability of the resource, cost, the appropriateness of the request, feasibility and prior work/avoidance of duplication. While all requests are considered, this communication does not in any way represent an obligation on the part of NCI/DCTD to conduct initial or follow on work or to provide materials to applicants/requestors. If you have any questions, please contact CADP at NCI_CADPinfo@mail.nih.gov.

Who: Researchers in academia, government and industry.

What: Access to tissue and laboratory resources for analytical and clinical validation of an assay to predict response to treatment or disease outcome. Available technologies will include immuno-histochemistry (IHC), in-situ hybridization (FISH and ISH), polymerase chain reaction (PCR and RT-PCR), and traditional Sanger based DNA sequencing. Microarray and massively parallel DNA sequencing (Next-generation sequencing) and mass spectrophotometer assay services may also be provided. Project management and timelines designed to assist development of the assay. For more information, visit About CADP.

Where: Online submission of CADP Application.

How: Eligibility for CADP requires an identified biomarker or signature, initial assay development, evidence that the assay can be used in human specimens, data on biomarker/signature prevalence, and a clearly defined intended clinical use. Successful application depends on favorable review of the project's scientific merit. For more information, visit Access to CADP Resources .

Sponsors: NCI’s Division of Cancer Treatment and Diagnosis, and the Cancer Diagnosis Program.

What CADP is not: CADP is not a grant or contract program. Rather, approved projects for the NCI CADP will be provided access to the Institute's assay development and validation resources.