A brief list of major EDRN-developed assays that have been adapted for clinical use is described in the table below:
|Detection/Biomarker Assay||Discovery||Refine/Adapt for Clin Use||Clinical Validation||Clinical Translation|
|Blood proPSA||✓||✓||FDA approved|
|Urine PCA3||✓||✓||FDA approved|
|OVA1™ for Ovarian Cancer||✓||✓||FDA approved|
|ROMA Algorithm for CA125 and HE4 Tests for Pelvic Mass Malignancies||✓||✓||FDA approved|
|Blood/DCP and AFP-L3 for Hepatocellular Carcinoma||✓||✓||FDA approved|
|Blood GP73||✓||✓||✓||Together with AFP-L3 used for monitoring cirrhotic patients for HCC in China|
|Urine/TMA assay for T2S:Erg fusion for Prostate Cancer||✓||✓||✓||In CLIA Lab|
FISH to detect T2S:Erg fusion for Prostate Cancer
|✓||✓||✓||In CLIA Lab|
|GSTP1 methylation for repeat biopsies in prostate cancer||✓||✓||In CLIA Lab|
|Mitochondrial deletion for detection of prostate cancer||In CLIA Lab|
|Somalogic 12-marker panel for Lung Cancer||✓||✓||In CLIA Lab|
|80-gene panel for Lung Cancer||✓||✓||In CLIA Lab|
|Vimentin Methylation Marker for Colon Cancer||✓||✓||In CLIA Lab|
|Galectin-3 ligand for detection of adenomas and colon cancer||In CLIA Lab|
|8-gene panel for Barrett's Esophagus||✓||✓||In CLIA Lab|
|SOPs for Blood (Serum, Plasma), Urine, Stool||✓||✓||Frequently used by biomarker research community|
EDRN Pre/Validation Specimen Reference Sets (specimens from well characterized and matched cases and controls from specific disease spectra)
|✓||✓||Frequently used by biomarker research community|
Since its inception in 1999 EDRN has achieved several key milestones, summarized below:
- 1998 through 2000: Inception and Inauguration of EDRN
- 2001 to 2003: Meeting the Challenges to Harness and Share Emerging Scientific Knowledge
- EDRN Second Report, Translational Research to Identify Early Cancer and Cancer Risk, October 2002, http://edrn.nci.nih.gov/docs.) published.
- EDRN joined the Gordon Research Conferences to co-host the New Frontiers in Cancer detection and Diagnosis in 2002.
- Guidelines Set for Studies Measuring Biomarker Predictive Power Journal of National Cancer Institute (Vol. 93, No. 14, July 18, 2001).
- EDRN Associate Membership Program Initiated: This novel approach to make EDRN inclusive has been extremely successful. EDRN has now more than 120 Associate Members who are significantly contributing to EDRN efforts in biomarker discovery, development and validation.
- 2003 to 2004: Network Surges Ahead in Real-time
- Collaborative Discovery and Validation Projects: More than 100 collaborative projects spanned the various organ sites. These projects are monitored through the EDRN’s electronic System Information System (eSIS).
- EDRN Virtual Specimen Bank and Validation Management System Launched: The EDRN Virtual Specimen Bank, also known as ERNE knowledge system, was deployed to 10 institutions in early 2003, allowing a common web-based query to search for available specimens across the EDRN Clinical Epidemiology and Validation Centers https://ginger.fhcrc.org/edrn/imp/GateServlet?pwd. VSIMS was created to allow multiple studies to be administered efficiently by minimizing development time with standardization of information and data management across multiple activities and research sites. This system encompasses all the security features of Food and Drug Administration (FDA)-required auditing systems.
- Partnership on the Plasma Proteome Project (PPP) Initiative of the Human Proteome Organization (HUPO): PPP project was initiated to evaluate multiple technology platforms, develop bioinformatic tools and standards for protein identification, and create a database of the plasma proteome. The entire study was published in the August issue of the journal Proteomics August 2005, Volume 4 (4), pp 1045-1450.
- 2005 to 2008: An Investment in Prevention
- In late 2006, EDRN’s Program for Rapid, Independent Diagnostic Evaluation (PRIDE), was established (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-07-003.html ) as an administrative means to assist extramural investigators in successfully conducting cross-laboratory validation of biomarkers. Ten applications have been reviewed and five are being supported.
- EDRN underwent external reviews in 2007 and 2008.
- The Canary Foundation, Palo Alto, CA signed a Memorandum of Understanding with EDRN, NCI on supporting prostate cancer surveillance network of investigators from seven institutions. The tissue and serum will be collected during a three-year period and will be made available to extramural scientists for discovery and validation research.
- The Lustgarten Foundation, N.Y., funded 6 institutions to generate monoclonal antibodies and associated hybridoma cell lines for pancreatic cancer antigens (biomarkers) identified by EDRN and non-EDRN investigators. These resources will be stored at the NCI-Frederick Facility for distribution to extramural investigators.
- 2009 to 2011: Realizing Investment for Clinical Use
- Two biomarker tests approved by FDA and two IVDs pending FDA review.
- Six biomarker tests offered by CLIA labs.
- One biomarker test approved for clinical use outside the USA