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U.S. National Institutes of Health
Last Updated: 10/31/11

CADP Resources for Assay Development

The services provided by the CADP will be aimed at delivering to the submitter analytically and/or clinically validated assays including documentation of good performance with the intended clinical specimen type. This is not grant support.

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 the DCTD Intellectual Property Advisor at 301-594-5318.

Most of the services will be provided by a contracted network of CLIA-certified laboratories. Other services will be provided by the NCI through direct contact (e.g., NCI statistical support and facilitation of interactions with regulatory agencies) or through other NCI-supported services.

Assays will be accepted at various stages of assay development and analytical validation and can enter the process any time at or beyond the earliest entry point (depicted in the figure). Therefore the services provided by the CADP may include many possible assessments required for analytical validation specific to the assay technology as well as post analytical validation, such as clinical validation testing. Specific services provided by the CADP will ultimately depend on the stage of assay development. The successful submitter will be part of the project team.

CADP marker development entry points and services
CADP marker development entry points and services
Click to enlarge

Initial discussions with the successful submitter will help determine the CADP services needed and detail CADP delivery timelines and potential exit points (e.g., if an assay is not capable of meeting the intended analytical performance criteria or if unexpected complications occur which delay timelines, etc., the project can be halted).

If required, after analytical validation of an assay, testing of cut-points and/or cut-point adjustments can be accomplished using a new set of retrospective clinical specimens. All associated SOP’s and instructions will be made available such that these assays can be successfully transferred (if needed) for use in CLIA certified laboratories for support of clinical studies.

Discussions with successful submitters will also include plans for the assay when it exits the CADP. Terms will be established, analogous to those used in therapeutics development assisted by the NCI, that will make clear the developer’s and the government’s rights and responsibilities to further develop the assay.

Services provided by the CADP will include:

  • Assessment of assay clinical readiness and discussion with the applicant of services required.

  • Assay optimization (if needed) with subsequent analytical validation including:
    • Design, manufacture and implementation of assay controls and/or assay standards and/or assay calibrators
    • Definition of critical reagent lot acceptance criteria
    • Definition of acceptable assay results required for reporting
    • Demonstration of assay analytical parameters:
      • Sensitivity
      • Specificity
      • Repeatability (within a laboratory and across multiple sites, if needed)
      • Precision
      • Assay limits (i.e. reportable assay ranges)
      • etc.
  • Testing of assay performance (e.g. cut-points) with retrospective sets of clinical specimens

  • Platform Migration: If a selected assay is currently not on an instrument platform or system that is best suited for clinical assay applications or cannot meet pre-defined analytical performance criteria it may be necessary to migrate to another instrument platform or assay system to improve the analytical performance.

  • Delivery of SOP’s for all aspects of assay (including pre-analytic steps) such that an assay can be successfully transferred to another CLIA certified laboratory

  • Statistical support to assist in clinical study design as part of assay clinical validation

  • Consultation and project management related to the development and intended use of a selected assay.

  • Matchmaking:
    • Assistance with transfer of an assay to a CLIA certified laboratory for use as part of a clinical study, which could include transfer of SOP’s, laboratory training, support for analytical validation in the new laboratory, samples provided for proficiency and lab to lab comparability studies, assay specific controls, calibrators and standards
    • Assistance with finding interested partners for regulatory submission and/or commercialization
  • Definition of the actual assay report, i.e., the analytical results of the assay, the claim being made and the intended use of the results of the assay.

  • Assistance with pre-IDE’s and submission of IDE’s may be available, e.g., facilitation of discussions between the developer and the FDA.

CADN — Clinical Assay Development Network

The Clinical Assay Development Network is a network of Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories that have been contracted to perform most of the laboratory-based services of the CADP. The CADN laboratories will provide services including assay optimization, assessment of analytical performance and clinical validity. Members of the CADN provide expertise in traditional assay platforms including immunohistochemistry, ELISA, in situ hybridization, quantitative real time PCR and DNA sequencing. Assay development services are provided to successful CADP submitters through contracts between CADN laboratories and the National Cancer Institute.

CADC — Clinical Assay Development Center

The Clinical Assay Development Center (CADC) is a National Cancer Institute laboratory that serves as a component of the Clinical Assay Development Network. The CADC will develop standardized assays that can be disseminated and will train external sites in assay performance. In support of the CADP, the CADC will develop and optimize robust validated novel genomic assays and platforms for support of clinical studies.

SRS — Specimen Retrieval System

The SRS is a contract project of the Cancer Diagnosis Program to find and gather archival pathology specimens, couple them with clinical annotations and provide them to the Clinical Assay Development Program. These specimens, in turn, will constitute the material which members of the Clinical Assay Development Network will use to test and refine assays within the Clinical Assay Development Program.

The SRS has contracted with two institutions of the NCI-funded Cancer Research Network (CRN), a group of 14 Health Maintenance Organizations particularly interested in cancer research. Institutions of the CRN were chosen for the SRS because they are large health plans, have stable membership and relatively long periods of enrollment, highly automated data systems with comprehensive electronic medical records and large numbers of archived pathology specimens dating back 3-4 decades. The CRN sites are involved in a number of ongoing joint cancer research projects and have a long record of research in the public domain.

The program uses a combination of the resources of the individual CRN site — pathology files, tumor registry, computerized medical record system — and a natural-language processing system developed at Harvard University. Most of the case finding has been done using the site’s tumor registry, essentially a database of all cancers diagnosed at that institution. This material is supplemented by codes and language from the pathology report and focused searches for diagnostic, treatment and outcome data from a number of sources. The records are fully deidentified using the Harvard processing system followed by a manual review of text to assure that all elements of Personal Health Identifiers (PHI) have been removed. A surplus block of formalin-fixed, paraffin-embedded tumor tissue is selected by the institutional pathologist and that block is forwarded to the CADP together with a file of clinical annotations.

The specimens will come from the routine clinical files of the sites and, as such, closely reflect cancers diagnosed and treated in the community setting. They have been diagnosed, treated and followed by community physicians. Though the assays may have been developed in a university, after they are perfected in the CADP they should closely mirror their subsequent use in the community. The CADP will perfect these assays using community-acquired and largely unselected cases that will likely mirror how the assays will be used in the future.

Note: At this time our access to blood samples is limited. If your project requires blood, please send an inquiry to before submitting an application.