Genomictree (CEO: Ahn Seonghwan) announced on June 30 that its U.S. subsidiary, Promis Diagnostics, has appointed Dr. Theo deVos as Senior Vice President.
Dr. Theo deVos is an expert with over 30 years of experience in the field of molecular diagnostics. He has a broad background covering the entire development cycle of diagnostic products, from early-stage product development to clinical trials, regulatory affairs, insurance, and commercialization.
In particular, during his tenure at the German diagnostics company Epigenomics, he led the development of the blood-based early colorectal cancer screening test Epi proColon, as well as obtaining FDA premarket approval (PMA), securing a CPT code, and listing for insurance reimbursement. He later served as CEO of Ares Genetics and as Vice President of Business Development at OpGen, contributing to the global diagnostics business.
Promis Diagnostics, Genomictree’s U.S. subsidiary, is responsible for the commercialization of in vitro diagnostic (IVD) products developed by Genomictree in the United States. The company has established a CLIA LAB and a CAP-accredited clinical laboratory, receiving certification from the U.S. government. It leads the entire process, including operating Laboratory Developed Test (LDT) services in the U.S., conducting clinical trials, obtaining FDA approval, and securing insurance reimbursement.
Recently, the company has been advancing related procedures for entering the U.S. market, focusing on non-invasive molecular diagnostic products for bladder cancer and colorectal cancer. The company stated that the recruitment of Dr. Theo deVos aims to strengthen the U.S. market entry strategy for its diagnostic products under development.
A representative from Promis Diagnostics said, "With the addition of Dr. Theo deVos, we will further advance our clinical trial approval strategies, regulatory responses, and commercialization strategies in the United States. In addition, by systematically executing key steps necessary for product commercialization, such as insurance coverage and adoption into relevant academic society guidelines, we plan to further enhance our competitiveness in the global molecular diagnostics market."
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