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Diagnostics and Clinical Laboratories

Our work in this critically important area spans the full range of issues faced by diagnostic companies and laboratories, and those collaborating with such entities. We have extensive experience under the regulatory frameworks governing testing under the Federal Food, Drug, and Cosmetic Act (FDCA); the Clinical Laboratory Improvement Act (CLIA); and state laws. Our work includes developing regulatory strategies for the development of companion diagnostics, advancing new models for providing laboratory testing to consumers, and supporting the deployment of COVID-19 diagnostic and serological testing. We routinely assist clients in obtaining optimal coverage and reimbursement for laboratory tests and diagnostics, and regularly assist in compliant collaborations for the development of diagnostics, such as companion diagnostics.