Andrew Westberg

Andrew (Andy) Westberg, MBA serves as Director of Clinical Operations at CovarsaDx, where he leads the execution and oversight of clinical studies for in vitro diagnostic (IVD) and medical device programs. He oversees clinical operations, project management, and logistics teams, ensuring studies are conducted efficiently, meet regulatory requirements, and deliver high-quality results for clients. Andy also provides strategic direction for study planning, operational execution, team development, and cross-functional collaboration across all phases of clinical research.

Prior to joining CovarsaDx, Andy spent more than 20 years leading clinical research programs for leading diagnostic and medical device companies. Most recently, he served as Senior Manager of Clinical Affairs at QuidelOrtho, directing studies that supported FDA clearances, CLIA Waivers, and international regulatory submissions. Earlier in his career, he held clinical and research leadership roles at Ibis Biosciences (Abbott Molecular), ICON, Biosite, and Accumetrics, where he gained broad experience in molecular diagnostics, cardiovascular and hematology testing, toxicology, and pharmaceutical clinical trials.

Throughout his career, Andy has authored numerous clinical study protocols and reports and has led clinical investigations that contributed to the successful commercialization of diagnostic products across multiple platforms. Recognized for his collaborative leadership style and commitment to professional development, he has built and mentored high-performing clinical research teams while helping organizations navigate complex clinical and regulatory pathways.