NCI Awards 18 Grants to Continue the Early Detection Research Network (EDRN) Biomarkers Effort

Date Posted: 

Monday, July 18, 2016

The NCI has awarded 18 grants to continue the Early Detection Research Network (EDRN), a national infrastructure that supports the integrated development, validation, and clinical application of biomarkers for the early detection of cancer. The awards fund 7 Biomarker Developmental Laboratories, 8 Clinical Validation Centers, 2 Biomarker Reference Laboratories, and a Data Management and Coordinating Center (DMCC).

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NCI's Early Detection Research Network and Cancer Diagnostic Tests

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Improving the Search for Biomarkers of Early Cancer

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Employing a team approach, the four major scientific components of the EDRN share a goal  to accelerate development of useful biomarkers of cancer risk, detection, diagnosis and prognosis, but also, importantly, to discard poor markers early on, avoiding fruitless efforts due to false leads and irreproducible early results.  The components have these roles:

Biomarker Developmental Laboratories (BDLs) focus on biomarker discovery and development that drives the subsequent steps in cross-laboratory validation in EDRN. The new awardees are primarily focused on ovary and gastrointestinal cancers, so a second funding opportunity was opened for projects focused on breast, prostate or other genitourinary organs, and lung cancer and cancers with rapidly rising incidence rates or with unique etiology.  Those applications are currently under review for award in 2017.

Clinical Validation Centers (CVCs) support and conduct biomarker validation trials, accrue specimens to be shared with other investigators, and participate in collaborative projects. The more than 100,000 high-quality, clinically annotated, serum, plasma, stool, tissue, and urine specimens collected as part of EDRN validation studies, already are an invaluable resource for concurrent and future validation studies.

Biomarker Reference Laboratories (BRLs) serve as Network resources for analytical and clinical validation of biomarkers. Approved under the Clinical Laboratory Improvement Amendments (CLIA), the BRLs participate in laboratory cross-validation studies and triaging of biomarkers, and serve as Network resources for technology development and refinement. BRLs help develop the “go, or no-go” decision processes that guide EDRN biomarker validation efforts.

The Data Management and Coordinating Center (DMCC) provides critical support for coordination of Network-wide activities and supports statistical analyses, data management and protocol development for biomarker validation trials.

In the 16 years since its inception, EDRN has made important progress in:

  • developing an organized effort for biomarker discovery, development and validation;
  • building resources to carry out this effort;
  • demonstrating the capabilities of several genomic and proteomic platforms;
  • identifying candidate biomarkers; and
  • conducting multi-center validation trials.

To date, the EDRN has facilitated the validation of six diagnostic tests that were approved by the FDA; produced 11 CLIA-approved tests; prompted more than 2,000 publications; and generated 28 patents and 14 licenses.

Listed in alphabetical order of their institution, the awardees are:

Biomarker Developmental Laboratories (RFA CA14-014)

Grant Number PI or Multi-PIs Contact PI's Institution Project Title
2U01CA152756-06 Sanford Markowitz
William Grady
Krishna Guda
Case Western Reserve University Biomarkers for Reducing Mortality of Cancers of the Colon and Esophagus
2U01CA152813-06 Hui Zhang
Ruedi Aebersold
Johns Hopkins University Glycoprotein Biomarkers for Early Detection of Aggressive Prostate Cancer
1U01CA200469-01 Zhen Zhang
Ie Ming Shih
Johns Hopkins University Development of In Vitro Diagnostic Multivariate Index Assay Using Liquid-Based Cervical Cytology Specimen and/or Serum/Plasma Biomarkers for the Detection of Early Stage or Low-Volume Ovarian Cancer
2U01CA152990-06 Steven J. Skates
Michael Birrer
Massachusetts General Hospital Proteomic, Genomic, and Longitudinal Pathways to Ovarian Cancer Biomarker Discovery
1U01CA200495-01 Louise C. Showe
Qihong Huang
The Wistar Institute Integration of Biomarker Signatures from Peripheral Blood for Diagnosis, Prognosis, Remission and Recurrence of Lung Cancer
2U01CA152753-06 Robert E. Schoen
Kenneth Kinzler
University of Pittsburgh ctDNA for the Early Detection and Monitoring of Colorectal Cancer
2U01CA152653-06 Brian B. Haab
Peter Allen
Randall Brand
Van Andel Research Institute Detection and Prognosis of Early-Stage Pancreatic Cancer by Interdependent Plasma Markers

Clinical Validation Centers (RFA CA-14-015)

Grant Number PI or Multi-PIs Contact PI's Institution Project Title
2U01CA113913-11 Martin G. Sanda Emory University Emory, Harvard & University of Washington Prostate Cancer Biomarker Center
2U01CA152637-06 Christopher I. Li
Charles Drescher
Paul Lampe
Fred Hutchinson Cancer Research Center Breast, Colorectal, and Ovary Cancer Clinical Validation Center
1U01CA200464-01 Jae K. Lee
Robert Gillies
John Heine
Matthew Schabath
H. Lee Moffitt Cancer Center & Research Institute Moffitt Imaging Biomarker Validation Center (Lung and Breast)
Gene P. Siegal
Upender Manne
University of Alabama at Birmingham UAB-EDRN Clinical Validation Center for GI Malignancies (Colon and Pancreas)
2U01CA086400-16 Dean E. Brenner University of Michigan Great Lakes New England Clinical Validation Center (Colon)
1U01CA200466-01 Randall Brand University of Pittsburgh Validation of Biomarkers for Early Diagnosis and Risk Prediction of Pancreatic Neoplasms
2U01CA086402-16 Ian Thompson
Robin Leach
University of Texas Health Science Center San Antonio Center for Biomarkers of Risk for Prostate Cancer (SABOR)
1U01CA200462-01 Robert C. Bast University of Texas MD Anderson Cancer Center MD Anderson Cancer Center EDRN-CVC for Early Detection of Ovarian Cancer
1U01CA200468-01 Anirban Maitra University of Texas MD Anderson Cancer Center A Clinical Validation Center for Early Detection of Pancreatic Cancer
2U01CA152662-06 Pierre Massion Vanderbilt University Validation of Biomarkers of Risk for the Early Detection of Lung Cancer

Biomarker Validation Laboratories (RFA CA-14-016)

Grant Number PI or Multi-PIs Contact PI's Institution Project Title
2U24CA115102-11 Daniel Chan Johns Hopkins University Clinical and Analytical Validation of Cancer Biomarkers
2U24CA115091-11 Sanford A. Stass University of Maryland Baltimore University of Maryland, Baltimore Biomarker Reference Laboratory

Data Management and Coordinating Center (RFA CA-14-017)

Grant Number PI or Multi-PIs Contact PI's Institution Project Title
2U24CA086368-16 Ziding Feng
Margaret Pepe
Mark Thornquist
Fred Hutchinson Cancer Research Center Early Detection Research Network: Data Management and Coordinating Center