Dr. Gary Spitzer, the MolDX Director for Clinical Validity and Clinical Utility Evaluation, will be chairing the morning session on Friday, June 23. In addition, Dr. Spitzer's own presentation will focus on "Clinical Utility Needs of ctDNA Assays versus Research Utility." Dr. Spitzer's presentation will focus on (a) the optimal use of transparent prospective registries and (b) ways that effective data can be gathered at lower costs.
Dr. Spitzer's Background
Dr. Spitzer has held a series of prominent national roles in oncology, including Deputy Director of the Bone Marrow Transplantion Program at M.D. Anderson, and clinical leadership roles at St. Louis University, Georgetown, and Bon Secours. He has been a senior clinical consultant to the MolDX program for almost two years, since March 2015. His LinkedIn webpage is here.
Rapid Advances in Liquid Biopsy
A lot has occurred between the First and Second Annual Liquid Biopsy Summits, with numerous policy advances in the field of Liquid Biopsy. For example:
- The FDA approved the Roche Cobas EGFR liquid biopsy test for several mutation sites (see JAMA, here).
- The FDA also held a joint all-day conference in Washington with AACR on liquid biopsy last July (here).
- NCCN guidelines recommend "If repeat biopsy [in lung cancer] is not feasible, plasma biopsy should be considered."
- ASCO's Year-in-Review for CY2016 featured two pages on the emerging clinical importance of advances in liquid biopsy (here).
- In the 21st Century Cures Act, Congress allocated $2B for new innovative cancer research, a substantial portion of which will go to public-private efforts in liquid biopsy.
- The dedicated liquid biopsy startup Grail announces plans to raise $1B while bringing on board the FDA's leader for precision medicine, Dr. Liz Mansfield.
The MolDX program has provided technical standards for the approval of liquid biopsy tests for coverage, here.