Nelson Hardiman has worked for multiple biomedical organizations developing or already utilizing genomic testing for a variety of purposes. Genomic testing involves complex issues in their development and introduction into the marketplace, as well as in the privacy, informed consent, and risk issues related to their usage. We have worked with providers engaged in the FDA approval process, and also work extensively with Laboratory Developed Test (LDT) testing compliance issues. Nelson Hardiman works with both early stage and public companies in this area, and can advise on the full range of regulatory, transactional, reimbursement, and risk issues.