The U.S. Food and Drug Administration (FDA) has frequently expressed concern about direct-to-consumer (DTC) marketing of genetic testing. For example, the FDA required pre-market approval for 23andMe’s Personal Genome Service. One of the FDA’s stated concerns is that in the case of DTC genetic tests no physician is involved to provide consumers guidance in utilizing these results and there is a danger that consumers will make their own decisions about treatment or use of prescription medicines that can create risks to their health. Recent studies provide some insight regarding consumers’ perceptions of these genetic test results. Impact on risk perception and decision making Consumers buying direct-to-consumer personal genome tests (DTC-PGT) want to believe good news, according to an article published in the September issue of Nature Biotechnology. While participants’ perception of their personal risk changed after receiving results showing decreased and increased risk, there was an "optimism bias"—with a greater change in perception resulting from good news. Additionally, the researchers found that following receipt of PGT results, consumers primarily seek medical attention in response to large, surprising results. Despite high-profile regulatory scrutiny of DTC-PGT [see box], there is not much evidence showing how use of these services impacts consumers’ medical […]