– Former U.S. Food and Drug Administration official will lead company’s product regulatory strategies and submissions
SAN FRANCISCO — (BUSINESS WIRE) — Freenome, a health technology company reinventing disease management through systematized early detection and intervention, today announced the appointment of Abraham Tzou, M.D., as Vice President, Regulatory Affairs. In this role, Dr. Tzou will be responsible for developing and implementing product regulatory strategies and for managing submissions to the U.S. Food and Drug Administration (FDA) and other regulatory authorities, as appropriate.
“Dr. Tzou joins Freenome at an exciting point in our growth and we are pleased to welcome him to the team,” said Girish Putcha, M.D., Ph.D., Chief Medical Officer at Freenome. “His expertise in regulatory strategy and his perspective as a former regulator will be invaluable as we develop and prepare to move our products through regulatory review here in the United States and abroad.”
Prior to joining Freenome, Dr. Tzou served as a Medical Officer at the FDA, Center for Devices and Radiological Health. While at the FDA, he led the clinical evaluation of in vitro diagnostic devices for cancer screening, companion diagnostics, cancer prognosis, genetic disorders and other emerging diagnostic tests. During his tenure at the FDA, he was recognized with a Group Recognition Award as part of the EXACT/CMS Parallel Review Team. He also earned the Outstanding Service Award for sustained and superior contributions to developing innovative approaches for molecular genetics and pathology devices, as well as a Special Citation for contributions to The BRAC Analysis CDx PMA.
Dr. Tzou holds bachelor degrees in Biomedical Engineering and Biological Sciences and an M.D. from Northwestern University. He trained in clinical pathology at Yale University.
“I am excited to join the team at Freenome, which is bringing a unique and forward-looking approach to advancing the field of disease detection and characterization and helping to deliver new technologies to better equip physicians and their patients with critical information towards improving outcomes,” said Dr. Tzou. “As we apply innovative approaches like machine learning in novel medical products, it’s critical that, as an industry, we work closely with regulators to ensure their safety and effectiveness for the people who will depend on them.”