Laura Esserman

Laura Esserman is a thought leader in cancer screening innovation and regulatory science who is shaping the pathway for MCED test approval and integration into existing cancer screening programs, advocating for adaptive trial designs that can efficiently demonstrate clinical utility while addressing regulatory requirements. Her work on the WISDOM trial (adaptive mammography screening) has established frameworks applicable to MCED integration with existing screening. She has articulated the regulatory science principles needed for FDA evaluation of MCED tests, including the novel challenge of evaluating a single test intended to detect dozens of different cancers. Her advocacy for evidence-based screening innovation is guiding the responsible implementation of MCED technology.