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Division of Cancer Prevention
National Cancer Institute - National Institutes of Health
U.S. Department of Health and Human Services
NCI-FDA-NIST Workshop on Standards in Molecular Diagnostics

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(PDF, 794kb)

Friday, December 07, 2012
NIH Neuroscience Building, Room C

8:00 am - 8:10 amWelcome & Overview
Nadarajen A. Vydelingum, PhD, FACB, NCI
8:10 am - 8:25 amIntroductory Remarks
Barry Kramer, MD, MPH, NCI
8:25 am - 8:45 amStandard Reference Sets for Expediting Clinical Validation of Biomarkers
Sudhir Srivastava, PhD, MPH, NCI
8:45 am - 8:50 amQ/A
Moderators: Nadarajen A. Vydelingum, PhD, NCI, Lakshman Ramamurthy, PhD, FDA
8:50 am - 9:10 amThe Role of Standards in Realization of Robust Molecular Biomarkers
Marc Salit, PhD, NIST
9:10 am - 9:20 amQ/A
9:20 am - 9:40 amStandardization of Molecular Biomarker Assays from Discovery and Development to the Clinical Laboratory: Lessons Learned
Sanford Stass, MD, University of Marylan
9:40 am - 9:50 amQ/A
9:50 am - 10:05 amCLIA/CAP Standardization from the Ground Up
Lynn Sorbara, PhD, NCI
10:05 am - 10:10 am Q/A
10:10 am - 10:30 amBreak
10:30 am - 10:50 amCase Study-Regulatory Aspects When Reviewing a Device - PCA3
Nisar A. Pampori, PhD, FDA
10:50 am - 11:00 amQ/A
11:00 am - 11:20 amThe Role of Bioinformatics in Standardization
Kristen Anton, MS, Dartmouth University
11:20 am -11:30 amQ/A
11:30 am - 11:50 amThe Role of the FDA pre-IDE as a Means to Improve Clinical Assays
J. Milburn Jessup, MD, NCI
11:50 am - 12:00 pmQ/A
12:00 pm - 12:30 pmPanel Discussion I
  • Transfer of research assays to assays validated for clinical use in a CLIA/CAP environment (requirements for SOPs, etc.)
  • Lessons learned related to assay development and application from research/developmental laboratories to clinical use
Panel Members: Frederick Barr, MD, PhD, NCI (Chair); Sanford Stass, MD, University of Maryland; Yun-Fu Hu, PhD, FDA; Jim Vaught, PhD, NCI; Lynn Sorbara, PhD, NCI

12:30 pm - 1:30 pmLunch Break (on your own)
SESSION II:What Has Worked? What Has Not? Where Are the Gaps?
Lynn Sorbara, PhD, NCI
1:30 pm - 1:50 pmPre-IDEs, IDEs and Related Submissions to FDA
Lakshman Ramamurthy, PhD, FDA
1:50 pm - 2:00 pmQ/A
2:00 pm - 2:30 pmCase Study - FDA Approval of OVA 1 Blood Test
(Co-presentation based on an application submitted to and approved by the FDA)
Daniel Chan, PhD, JHU/Marina Kondratovich PhD, FDA
2:30 pm - 2:40 pmQ/A
2:40 pm - 3:00 pmBreak
3:00 pm - 3:20 pmStandards of Operation and Best Practices for Future Biomarker Evaluation
Robert Christenson, PhD, University of Maryland
3:20 pm - 3:30 pmQ/A
3:30 pm - 3:50 pmWhole Genome, High Density Platforms, Standards, and New Approaches to Evaluation of Molecular Assays
Zivana Tezak, PhD, FDA
3:50 pm - 4:00 pmQ/A
4:00 pm - 4:20 pmFrom Validation to Qualification of Biomarkers and Alternative Paths
Federico Goodsaid, PhD Vertex Pharmaceuticals
4:20 pm - 4:30 pmQ/A
4:30 pm - 4:50 pmPanel Discussion II
  • What has been done well on the landscape of standards in molecular diagnostics?
  • What are the remaining gaps and what needs improving?
Panel Members: Henry Rodriguez, PhD, NCI (Chair); Federico Goodsaid, PhD, Vertex Pharmaceuticals; Robert Christenson, PhD, University of Maryland; Daniel Chan, PhD, John Hopkins University; Marina V. Kondratovich PhD, FDA
4:50 pm - 5:00 pmClosing Remarks
Nadarajen A. Vydelingum, PhD, NCI
5:00 pmAdjournment

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