As innovators across the healthcare and life science industry seek out Nelson Hardiman’s guidance, genomics has become an increasing area of the firm’s advice and representation. Nelson Hardiman was ranked as a “Tier 1” law firm in 2022 by US News and World Report for its groundbreaking work in the life sciences industry. We counsel both emerging and mature public companies, including leading developers and providers of genomic testing, on strategy, regulatory compliance related to FDA requirements for Laboratory Developed Tests (LDTs), CLIA compliance, the intersection of corporate practice of medicine (CPOM) and testing, data privacy and security, licensing agreements, avoidance of fraud and abuse risks, financial capitalization, and M&A. Our extensive experience includes LDT testing, direct-to-consumer (DTC) genetic testing, gene therapy, transgenic technologies, predictive health modeling, proteomics research, and other bio-technologies.