Under Yunfu’s leadership, Genetron Health’s blood-based next-generation sequencing (NGS)
test, HCCscreen™️, received Breakthrough Device designation from the U.S. Food and Drug
Administration (FDA), which made it the first product in China's molecular diagnostic industry
to achieve this recognition.
Yunfu previously served as Deputy Director of the Division of Molecular Genetics and
Pathology in the Office of In Vitro Diagnostics and Radiological Health, Center for Devices and
Radiological Health at FDA. He was responsible for supervising in vitro diagnostic products such
as cancer molecular diagnosis, companion diagnostic products, gene testing, artificial
intelligence in pathology and cytological detection.
Some of Yunfu’s notable FDA approvals include: Myriad Genetics' BRAC Analysis CDx;
Foundation Medicine's FoundationFocus CDxBRCA; ThermoFisher Oncomine Dx Target Test;
FoundationOne CDx; Roche Cobas EGFR Mutation Test v2; Exact Sciences’ Cologuard and Epigenomics’
Epi ProColon.
Yunfu has 10 years of product development experience with world-class diagnostic and
pharmaceutical companies. He has made outstanding achievements in precision medical research,
tumor biomarker development and diagnostic product development and registration.
Yunfu obtained his Ph.D. in Veterinary Physiology & Pharmacology and Master’s degree in
Reproductive Endocrinology at Ohio State University. He was Postdoctoral Fellow of Fox Chase
Cancer Center.