Co-Diagnostics, Inc. appoints chief regulatory affairs officer

Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced that it is pleased to welcome Ivory Chang as the Company’s Chief Regulatory Affairs Officer.

Chang’s in-depth regulatory affairs experience has included time spent with several notable names in the diagnostics industry, including Roche, Boston Scientific, BD Biosciences, Cepheid, Thermo Fisher Scientific, and more. Her background has involved regulatory and registration submissions to major regulatory bodies around the world for infectious disease, oncology, point-of-care, in vitro diagnostics (IVD), and software diagnostic products.

Dwight Egan, Company CEO, commented “We are pleased to welcome someone with Chang’s vast industry experience to the management team at Co-Dx. We believe Ivory’s skillset and impact in advancing our future regulatory submissions for our planned, expanding pipeline of products will help to further the Co-Dx vision of increasing the accessibility of state-of-the-art molecular diagnostic solutions, both for our legacy in vitro diagnostics products as well as our forthcoming Co-Dx PCR Home™ platform.”

“I am excited to be able to draw on my years of regulatory experience when we pursue clearance for the Company’s exciting new platform and prepare it for the initial launch,” remarked Chang. “The innovation of the Co-Dx PCR Home platform attracted me to playing an active role in supporting the Company’s efforts as the world shifts to a more decentralized approach to diagnostics, as well as the efforts of our existing and planned IVDs for high-complexity clinical laboratories.”
MB Bureau