Submitted to FDA’s Molecular and Clinical Genetics Panel of Medical Devices Advisory Committee on May 2, 2011:

In the US, we have a recognized lack of trained genetic counselors and physicians to support the interpretation of genomic information. FDA must address how we will educate healthcare professionals in sufficient numbers to assist with interpretation. Until then, US-based DTC genomics companies such as 23andme, Navigenics, Counsyl and others provide valuable education services to consumers about certain genetic conditions. By requiring informed consent, providing responsible information, and making no claims, these companies must continue their innovative work with a minimum of regulatory oversight because they fulfill an unmet need in our healthcare system. Also, since genomic testing is easily offshored, requiring a medical professional’s signature will not deter consumers from obtaining this information. Consumers want transparency from DTC genomics companies and generally want choice when deciding how their genomic information will be shared with others. Government plays two critical roles in this process: 1) ensure trust in DTC genomic results through regulatory standards such as CLIA, and 2) enforce the privacy of genomic information through regulatory acts such as HIPAA and GINA.