Informal Request for Public Comment: "Direct-to-Consumer" Genetic Testing
At the request of Del. Shane Pendergrass, Vice Chair of the Health and Government Operations Committee, the Department of Health and Mental Hygiene conducted a review of the laws and policies of other states and conducted a literature review on the potential harms and benefits of allowing direct-to-consumer genetic testing (DTC) in Maryland. Since that time, the Department has completed a review of the literature on the harms and benefits, as well as the clinical utility of services offered by DTC companies. Additionally, the Department has included a review of an expanded set of state policies and laws that have been used to protect consumers in their interaction with DTC genetic testing companies. The review is available here
The Department is now seeking public input and would like to receive comments on the following questions relating to direct-to-consumer genetic testing:
1. Whether consumers should have direct access to genetic testing.
2. If direct access to genetic testing is authorized, what types of consumer protections (if any) should be included, such as:
· Quality controls;
· Disclosure requirements;
· Requirements for access to genetic counselors as part of the testing package; and
· Privacy requirements for companies conducting the testing.
3. If direct access to genetic testing is authorized, whether and what types of testing should be prohibited (such as testing for the breast cancer (BRCA) gene or other high risk tests with clinical significance, or for prenatal testing of fetuses).
Comments may be emailed to Christi Megna, at email@example.com or mailed to her attention at 201 W. Preston St., Baltimore, MD 21202 on or before November 26, 2013.