ABSTRACT
The challenge for government and policy makers is to develop a regulatory framework sufficiently stringent to ensure that only tests that are sufficiently robust and useful are offered to patients and refunded by health care payers. Direct-to-consumer genetic testing (DTC-GT) claims to have placed genomics directly into the hands of consumers by allowing patients to easily obtain information about their genetic makeup, sometimes without having to even see a doctor, genetic counselor, or pharmacist. The type of DTC genetic tests being offered to the public varies from testing for lifestyle factors, nutrigenomics, ancestry, rare diseases, and susceptibility for common chronic diseases and includes pharmacogenetic testing for drug responses. Pharmacogenomic research is a promising discipline that could have a substantially positive impact on pharmaceutical development and population health in the future. Like research in most other biomedical fields, it raises its share of ethical, legal, and social issues.
