Diagnostics

Our work addresses the diverse challenges faced by diagnostic companies, laboratories, and their collaborators. Members of our team hold advanced scientific and medical degrees with experience in genomics and personalized medicine that enables us to guide clients through the evolving landscape of next-generation sequencing, companion diagnostics, AI-enabled diagnostic decision support, and laboratory-developed tests. We provide advice on the regulatory frameworks in the U.S., Europe, and China, and our deep understanding of government and industry bodies facilitate practical changes to the legal framework to minimize business disruptions.

We routinely represent companies on complex licensing and collaboration diagnostics and technology platform transactions; assist them in internal investigations and government enforcement matters; counsel lawyers and business leaders on legislative and agency engagement related to coverage, reimbursement, and related policy; defend and enforce intellectual property rights; and counsel on critical FDA, Clinical Laboratory Improvement Amendments (CLIA), and other regulatory matters. Additionally, our team guides clients on the evolving regulatory landscapes for Laboratory Developed Tests (LDTs) in the U.S. and for Invitro Diagnostic Regulation (IVDR) in Europe.