DYD, MOU for US FDA Approval..."Saliva Diagnostic Kit Clinical Trials Begin in Earnest"

From the left, Se-young Ahn, Director of DYD Technology Research Institute, and Dr. Sherry Dadgar, CEO of PMCDx. DYD

DYD announced on the 16th that it will actively pursue FDA approval for its saliva-based diagnostic kit in collaboration with a U.S. clinical institution. To this end, clinical trials will be conducted through CLIA Lab, which can optimize time and costs.

DYD signed an MOU with PMCDx, a clinical contract research organization (CLIA Lab) located in Montgomery County, Maryland, USA. A CLIA Lab refers to an FDA-certified clinical trial institution. PMCDx covers 48 states in the U.S. A DYD company representative stated, "Using the CLIA Lab allows us to use our internally developed Laboratory Developed Test (LDT) without separate FDA approval, saving the costs and time required for FDA approval."

The partnership with PMCDx was made upon the recommendation of Montgomery County, with which DYD signed a soft-landing agreement on the 4th of last month. PMCDx has shown special interest in DYD's diagnostic kit and submitted a Letter of Intent (LOI) expressing their desire to provide clinical trial data and use the product. DYD also reported that it is in close consultation with Globizz, a U.S. FDA specialized consulting firm, to expedite FDA approval. Furthermore, the company explained that it plans to pursue clinical trial support through MIPS, the clinical trial support program of the University of Maryland, which is also actively recommended by Montgomery County.

During the clinical period, DYD plans to collaborate with the University of Maryland team to collect data and conduct AI research using the U.S. Medical Digitalization Service (MD IHC), as well as jointly develop the latest technologies for diabetes treatment.

DYD plans to sign the main contract with PMCDx in May, begin recruiting clinical trial participants in June, and complete the clinical trials within 2025.