Genetic Testing

This information is meant to be used for educational purposes to inform providers, patients, and genetic service delivery stakeholders about genetics policy topics. Sharing of information, resources, or policy statements is no way an endorsement of stated positions by NCC.

Introduction

Genetic tests help individuals determine their genetic make-up. These tests can look at the individual’s DNA, other genetic material, or other health factors. Genetic tests can help diagnose disease, predict one’s risk of developing disease, or identify disease severity. These tests can be done at any stage of one’s life, from before birth to after death.

There are many policy areas that overlap with genetic testing. Please visit those pages for a more in-depth discussion. Some of those policy areas include:

• Adoption and Genetic Testing
• Ancestry Testing
• Direct-to-Consumer Testing
• Gene Patents
• Genetic Discrimination
• Genetic Privacy
• Informed Consent
• Laboratory (regulation/oversight)
• Laboratory Developed Tests (LDTs)
• Pediatric Genetic Testing
• Secondary Findings

Legislation and Regulation

Genetic tests are regulated at a federal level by the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Federal Trade Commission (FTC). For more information on how tests can be evaluated, review the National Human Genome Research Institute (NHGRI) website page about genetic testing.

Additionally, some states place additional regulations on genetic tests. The National Human Genome Research Institute (NHGRI) has also cataloged individual state statutes and legislation, which can be accessed here.

Are you interested in learning what your state’s government or the federal government are currently proposing for either legislation or regulation? Check out Legislative/Tracking system for up-to-date information and subscribe to our Twitter channel to get the latest updates in your pocket.

Policy Positions