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Following the read-out of Guardant Health’s ECLIPSE study, the big debate is on FDA approvability of the Shield assay in CRC screening. On April 12th, Jack Meehan hosted two former FDA leaders to discuss Shield’s clinical data in ECLIPSE, FDA considerations for approval of the test built on historical experience, and the potential approval pathway for liquid biopsy.
Andrea Chamblee, former FDA Director & senior counsel in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati.
Dr. Sousan Sheldon, President of Medical Consultants, LLC.
By Nephron Research LLCFollowing the read-out of Guardant Health’s ECLIPSE study, the big debate is on FDA approvability of the Shield assay in CRC screening. On April 12th, Jack Meehan hosted two former FDA leaders to discuss Shield’s clinical data in ECLIPSE, FDA considerations for approval of the test built on historical experience, and the potential approval pathway for liquid biopsy.
Andrea Chamblee, former FDA Director & senior counsel in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati.
Dr. Sousan Sheldon, President of Medical Consultants, LLC.