Announcement of the NCI Early Detection Research Network (EDRN) Program for Rapid, Independent Diagnostic Evaluation (PRIDE) for Cancer Biomarkers

Notice Number: NOT-CA-07-003

Key Dates
Release Date: October 20, 2006

Issued by
National Cancer Institute (NCI) ( )

The National Cancer Institute's Early Detection Research Network (EDRN; ) announces a new opportunity for support of collaborative research on biomarker validations for risk assessment and early detection.

Established in 2000, the EDRN is focused on translating new molecular knowledge into practical clinical tests that identify cancers at the earliest stages of normal cells' transformations into cancer cells, and to identify individuals at risk of developing cancer. The EDRN is structured around four main components, including: (1) Biomarkers Developmental Laboratories, which develop and characterize new biomarkers, or refine existing biomarkers; (2) Biomarkers Reference Laboratories, which serve as resources for clinical and laboratory validations of biomarkers, including technological development, standardization of assay methods, and refinements; (3) Clinical Epidemiology and Validation Centers, which conduct and support the early phases of clinical and epidemiological research on the utilization of biomarkers; and (4) a Data Management and Coordinating Center, which develops the theoretical statistical approaches to pattern analysis of multiple markers simultaneously. EDRN supports studies on the development and clinical validations of biomarkers, and the creation of standard operating procedures for assays, methodologies, and sample preparations. Through its resources for serum reference samples, technologies, informatics, and reference laboratories on validation, EDRN supports investigators by helping them with rapid evaluations of the reproducibility, portability, and precision of their technologies and biomarker assays.

EDRN hereby announces the establishment of the Program for Rapid, Independent Diagnostic Evaluation (PRIDE), which is an administrative means by which it can assist extramural investigators in the successful conduct of cross-laboratory validations of biomarkers, including the development, refinements, and uses of new and existing assays, reagents, methods, and tests.

Interested investigators are invited to submit two- to three-page-long (maximum) descriptions of their biomarkers that meet the criteria for Phase II or Phase III validations as described in the Journal of the National Cancer Institute 93(4), 1054 -1061, 2001. Request-for-validation-support letters containing descriptions of biomarkers meeting the eligibility criteria are accepted on a continuous basis throughout the year. There is no restriction on the number of these letters that an investigator can submit; however, a separate request-for-validation-support letter will be required for each organ site (i.e., for the one or more biomarkers that are proposed for validation studies in association with cancer of a specific organ site). If selected, an investigator will be invited to present the proposed biomarker validation study (or studies) to the relevant EDRN Collaborative Group as part of the further evaluation. Funding for PRIDE will be provided through the EDRN's Set-Aside funds for biomarker validations.

For further details on PRIDE and for information regarding the format and special requirements of the request-for-validation-support letters, go to the NCI's Request-for-Biomarkers web site at .


We encourage your inquiries concerning this program and welcome the opportunity to answer questions from potential applicants. Inquiries and request-for-validation-support letters should be directed to:

Donald Johnsey
Division for Cancer Prevention

National Cancer Institute
6130 Executive Boulevard, EPN Room 3148, MSC 7362
Bethesda, MD 20892-7362 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 435-5015
Fax: (301) 402-8990

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