Maine Molecular Quality Controls

MMQCI continues to design and produce innovative, high-quality control products as needed for emerging nucleic acid technologies as they come into use by the molecular diagnostic community. Custom orders from in vitro diagnostic manufacturers are always welcome at MMQCI's cGMP facility. The company was formed in January 2000 by the two principals, Joan Gordon MT (ASCP) and Clark Rundell, Ph.D. Both founders of MMQCI have a strong background in clinical laboratory testing, as well as extensive research and development skills in the molecular biology field. As long-term workers in a clinical laboratory at Maine's largest healthcare facility, they are thoroughly familiar with the importance of controls in assuring laboratory accuracy, as well as the Federal regulations governing their use. While implementing novel genetic testing assays in the newly established Maine Medical Center Molecular Pathology Laboratory, Dr. Rundell invented and patented a process to stabilize target DNA constructs for utilization as controls in molecular-based diagnostic assays. Ms. Gordon, President of MMQCI, developed protocols based on this patented process to manufacture an FDA-cleared quality control for an infectious disease test platform. Dr. Rundell and Ms. Gordon subsequently founded MMQCI to pursue further research and development of unique technologies to produce additional molecular control products. Funds from the National Institutes of Health and Maine Technology Institute have assisted the development of new technologies used in MMQCI products.