Dr. Karen L. Shannon

Karen L. Shannon, PhD, JD, brings more than two decades of legal, intellectual property, and regulatory experience in the diagnostics and biopharmaceutical industries to her role as in-house counsel for CovarsaDx. A strategic advisor and seasoned life sciences attorney, Karen has built her career helping organizations navigate complex IP landscapes, regulatory pathways, and commercial agreements that shape the development and adoption of diagnostic technologies.

Karen joined CovarsaDx after serving as Senior Vice President and General Counsel for SeeGene USA, where she established the company’s first U.S. legal organization and led all legal and compliance functions. In this role, she partnered closely with R&D, regulatory, quality, and business development teams, providing guidance on intellectual property strategy, risk governance, and the legal frameworks supporting new product development and U.S. market entry.

Previously, Karen spent more than a decade at Danaher Corporation in leadership roles across its global diagnostics platform. She served as Vice President of Intellectual Property for Beckman Coulter Diagnostics and Assistant General Counsel for Danaher’s Diagnostics Platform, directing global patent and trademark strategy, supporting FDA submissions and European CE-mark filings, managing complex international litigation, and conducting IP diligence for major acquisitions. Her work spanned immunoassay, hematology, microbiology, automation, and software portfolios, supporting product launches in diverse regulated markets.

Karen’s role at CovarsaDx reflects the organization’s continued growth and commitment to strong, proactive compliance. She partners with the company’s regulatory, quality, and clinical teams to support responsible scale while helping guide the thoughtful integration of AI and automation into clinical operations. Her expertise strengthens CovarsaDx’s ability to anticipate regulatory expectations, develop sound legal foundations, and ensure innovation is balanced with responsibility.

Karen holds a PhD in Bio-organic Chemistry from the California Institute of Technology and a JD from Georgetown University Law Center. She is admitted to practice before the U.S. Patent and Trademark Office, multiple state bars, several federal courts, and the Supreme Court of the United States.