Matthew Boisen, PhD
Director of Diagnostics Development
Dr. Boisen has broad expertise in in vitro diagnostic product development focused on rapid, point-of-care diagnostics for detection of infectious diseases and biowarfare agents. His background in diagnostic methodology includes Lateral Flow Immunoassay, ELISA, optical biosensors and micro-array platforms spanning manual, semi-automated and fully automated systems. Dr. Boisen has over 25 years’ experience managing numerous GLP and GMP compliant development projects through experimental design, field trials, design validation and verification through regulatory approval to commercialization.
Prior to joining Zalgen, Dr. Boisen directed the infectious disease product development program at Corgenix Medical Corporation resulting in numerous rapid diagnostic tests (RDT) for Lassa and Ebola Hemorrhagic Fevers. These products included two breakthrough tests: the ReEBOV Antigen Rapid Test, the first and still only rapid immunological test to receive both FDA Emergency Use Authorization and the WHO Emergency Qualification Listing, and the ReLASV Rapid Test, the first viral hemorrhagic fever RDT to be CE marked for IVD use. Prior to Corgenix, Dr. Boisen worked at Thermo BioStar, Inc. developing rapid biosensor assays including STEC OIA® for the detection of Shigella-like Toxin and GC OIA® for the detection of N. gonorrhea antigen both of which received FDA 510(k) clearance. He has also managed development projects for respiratory disease (Influenza and atypical pneumonia), enteric pathogens (G. lamblia and E. histolytica), and toxins (Staphylococcus enterotoxin B). Dr. Boisen has a BS degree from San Jose State University and a PhD from Tulane University School of Medicine.
Dr. Boisen is the site manager for Zalgen’s Colorado operations and directs the diagnostic products business including grant management, product development, regulatory compliance, production, submission of scientific publications, and interaction with external collaborators including the NIH, FDA, UNICEF, and WHO.