Freenome has appointed Abraham Tzou as its VP of regulatory affairs. Tzou will be in charge of regulatory strategy for products developed by Freenome and manage submissions to the US Food and Drug Administration and oversight bodies abroad.
Tzou joins Freenome after serving as a medical officer at the FDA's Center for Devices and Radiological Health, where he led the clinical evaluation of in vitro diagnostics for cancer screening and prognosis, genetic disorders, and companion tests. During his tenure at the agency, he received commendation for his part in a team that reviewed Exact Sciences' non-invasive, colon cancer screening test Cologuard for parallel review.
Freenome is developing a non-invasive cancer screening technology that involves genome-wide sequencing and a computational system, called Adaptive Genomics Engine. The company is interested in pursuing Parallel Review for this technology, which if successful, would enable simultaneous FDA approval and a national coverage determination from the Centers for Medicare & Medicaid Services.