abstract: Effect of genome-wide association studies, direct-to-consumer genetic testing, and high-speed sequencing technologies on predictive genetic counselling for cancer risk : The Lancet Oncology

full free access: Preparing for a Consumer-Driven Genomic Age Health Policy and Reform

"Advances in genomic technologies permit the simultaneous analysis of millions of variants across the genome and may soon allow for meaningful estimation of one’s risks of developing cancer, diabetes, and other common diseases. These advances are converging with the movement toward consumer-driven health care and patient empowerment. Whereas in the past, medical testing was firmly under the control of medical practitioners, genomic information is now increasingly available outside traditional medical settings. Patients are no longer subordinate, passive recipients of physician-initiated genetic testing; rather, patients can instigate their own testing and often know more than their clinicians about particular genetic topics. Indeed, health care providers are increasingly bypassed altogether, as patients embrace direct-to-consumer (DTC) genetic tests and turn to social networks for help in interpreting their results. In the future, a primary role of health care professionals may be to interpret patients’ DTC genetic test results and advise them about appropriate follow-up. How can we maximize the benefits of these new developments and minimize the harms? How can we encourage patients’ involvement and autonomy yet establish appropriate safeguards while avoiding inappropriate paternalism? How do we promote the understanding that interpretations of genomic information may evolve as research unravels the meaning of gene–gene and gene–environment interactions and the roles of noncoding DNA sequences, copy-number variants, epigenetic mechanisms, and behavioral factors in health and disease?..."cont'd

FDA to Hold Hearing on Regulation of Consumer Genetic Tests - WSJ.com

Genetic Tests and FDA (U.S.)

FDA will convene a public meeting next week to hear from companies that make direct-to-consumer genetic tests, before it begins an overhaul of its regulations on genetic diagnostic testing,

Informational content, literacy demands, and usability of websites offering health-related genetic tests directly to consumers