Dennis Broyles

Dennis Broyles has over thirty-five years of experience with in vitro diagnostics and in clinical research. An accomplished clinical trial manager, he has a proven track record of successful clinical trial completion with regulatory approvals in the US (PMA, de novo 510(k), 510(k), EUA) and OUS. His diverse skill set includes all aspects of clinical operations including strategic planning, protocol development, and data management and results interpretation in various diagnostic areas including urology (prostate and bladder cancer, BPH), women’s reproductive health (fertility, ovulation prediction), oncology, infectious disease (CMV, MRSA, HBV, STDs, Flu A & B, RSV, COVID-19), hematology (stem cell transplantation), immunology (stem cell and solid organ transplantation), digestive and kidney diseases (IBS, AKI), bone remodeling, and asthma & allergy diagnostics. Prior to joining CovarsaDx®, he worked at Beckman Coulter and Hybritech, Inc. where he played a key part in the product launches of the Prostate-Specific Antigen (P850048-S012) and Ostase (k972666, k994278) assays. Dennis also helped acquire FDA PMA (P090026) approval for [-2]proPSA and the prostate health index, and FDA de novo 510(k) clearance (k051122) for the first tetramer based flow cytometry assay.

Dennis has co-authored publications on topics including reproductive health and prostate cancer for various journals including Clinical Chemistry; British Journal of Urology International; Prostate Cancer and Prostatic Diseases; and Cancer Epidemiology, Biomarkers & Prevention. He also co-authored the 3rd edition of Management of Prostate Cancer, published by Humana Press.

Dennis received his MSHS in Clinical Research Administration from the George Washington University and holds a BA in Biology from the University of California, San Diego. He also has a Regulatory Affairs Certification (RAC), and is CCRA and CCRP certified through ACRP and SoCRA, respectively.