When it comes to DTC genetic testing, everyone has an opinion. AMA wants access to genetic information to be restricted to people who are directly under a doctor's care, while others say that people should have access to their genetic information whenever they want it. FDA is trying to sort through the various recommendations, and met this week to discuss how best to regulate the DTC genetic testing industry, say a group of bloggers at Genomes Unzipped. FDA officials have indicated that decisions about the availability of the tests will be made on a case-by-case basis, although no official policy has been announced. It is a complicated issue, but there are a few things that all of the bloggers at Genomes Unzipped agree about. First, "Individuals have a fundamental right to access information about themselves, including genetic information." While it's important to consider the accuracy, validity, and interpretation of the tests, the underlying principle of access to information should be guiding policy, the authors say. They also agree that there is no evidence of any DTC test posing a danger to consumers, that most clinicians don't have the proper training and education to interpret the tests correctly, and that most early adopters of DTC genetic testing are well-enough informed to understand the implications of the results. "While the outcome of the FDA's deliberations remain uncertain, it is clear that there will be intensive lobbying against any attempt at excessive legislation," the bloggers write. "We urge others in the genomics community to make their voices heard on these issues."
Our sister publication GenomeWeb Daily News has more on the FDA panel here.