Genetic Tests Sold Direct To Consumers Should Be Supervised By Doctors Says FDA Panel (and the debating issues)

full free access: Effect of Direct-to-Consumer Genomewide Profiling to Assess Disease Risk — NEJM

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