Background
Dr. Kong has almost 10 years of experience in In Vitro Diagnostics (IVD) in numerous disciplines, ranging from next-generation sequencing technologies in cancer detection to over-the counter tests for the detection of respiratory viruses. He possesses significant regulatory expertise in the review of premarket submissions from his time with the FDA, where he first served as a scientific reviewer and later oversaw reviews as a Team Lead. From his time in industry, Dr. Kong is also keenly familiar with the logistics and challenges encountered during the development of a new IVD test, from initial concept and preliminary testing through clinical trial implementation and regulatory approval. Across his career, Dr. Kong has worked across wide breadth of biomedical devices and subject areas, including cancer diagnostics, diabetes glucose monitors, drugs of abuse, respiratory viral tests, digital health technologies, and real-world evidence.
Education
Bachelor of Science degree in Biology from Stockton University.
Ph.D. from the University of Maryland, Baltimore, in Molecular Microbiology and Immunology, with a focus in microbial pathogenesis. His doctoral thesis was focused on antimicrobial resistance and tolerance mechanisms in polymicrobial biofilm infections, involving Candida albicans and Staphylococcus aureus.
Experience
Prior to joining MCRA, Dr. Kong worked in the Division of Microbiology Devices (DMD) at the FDA for 4.5 years. As a Team Lead within the Bacterial Respiratory and Medical Countermeasure Branch, he conducted and oversaw the scientific and regulatory review of hundreds of premarket applications submitted to FDA, including De Novo submissions, 510(k)s, Pre-submissions, Emergency Use Authorizations (EUA), and pre-EUAs. Therein, Dr. Kong specialized in the review of respiratory viral antigen testing devices, primarily SARS-CoV-2 (i.e., COVID-19), Influenza A and B, and Respiratory Syncytial Virus (RSV). His work there was also focused on developing guidances, recommendations, and the regulatory pathways for Over-the-Counter test devices for respiratory viruses. He was also involved with several inter-office working groups within CDRH, focused on developing and harmonizing the Center's approach towards the utilization of Real-world Data and Evidence in support of an IVD premarket submission. Before he joined DMD, he also served as a reviewer within the Division of Chemistry and Toxicology (DCTD), within the Toxicology Branch. Prior to the FDA, Dr. Kong worked for Personal Genome Diagnostics (now under LabCorp), which focused on utilizing Next-Generation Sequencing technologies and machine-learning algorithms for cancer diagnostics, in both solid tissue and liquid biopsy samples. He was a member of their Translations Science and Diagnostics Team, providing key scientific, clinical, and regulatory support across the company.
Overview
Dr. Kong brings his in vitro diagnostics regulatory expertise to MCRA’s FDA & Global Regulatory department. Within the In Vitro Diagnostics Regulatory Affairs group, Dr. Kong focuses on developing and executing regulatory services for clients. While his primary focus is to support premarket efforts by informing on regulatory strategy and development of medical devices through design and review of analytical and clinical testing, Dr. Kong collaborates with other MCRA departments, including reimbursement and quality assurance, to ensure that client companies receive comprehensive guidance regarding all aspects of the commercialization of their products.