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And, to top it all off, there are very few cases where knowing your risk status or other phenotype points to genotype-specific actions (with the BRCA status referred to in the FDA letter a notable exception). One the one side you have people who argue that the data are so messy, of so little practical value, and so prone to misinterpretation by a population poorly trained in modern genetics that we should not allow the information to be disseminated. But I do think we have to figure out a way for companies that provide this kind of information to be effectively regulated.
The data are, at this point in time, very very messy. The challenge is to come up with a regulatory framework that recognizes the fact that this information is – at least for now – intrinsically fuzzy.
Few consumers have the capacity to judge on their own whether the genetic testing services provided by a company are accurate and whether interpretive information provided by third parties is valid.
It is vital that the FDA protect consumers in two ways: 1) by validating the tests and the companies that provide them, and 2) by monitoring genetic information that is provided by consumers – especially if it is being used to market tests or other products.
I don’t think the FDA should restrict consumer access to their genotype or DNA sequence, but I do think the government has an important role to play in ensuring that consumers get accurate information and that the data are not oversold in the name of selling products.
As people try to decide what kinds of tests and information should be available and how the government should regulate them, I think it’s useful to ask a series of questions.
Genetic tests are simply not – at least not yet – medical devices in any meaningful sense of the word.
They are far closer to family history than to an accurate diagnostic.
I see a wide range of opinions from my friends on this matter – ranging from “F**k the FDA – who are they to tell me what I can and can not learn about my DNA” to “Personalized genomics is snake oil and it’s great that the FDA is stepping in to regulate it”.
Assuming someone has their own genome sequence, it would be hard to argue they shouldn’t have access to information that would allow them to understand what their genome means.
Which leads to: 3) Is there a role for third parties in helping people interpret their genome sequence? – and use various automated tools to extract what is known about their genotype.
You might not think they provide a valuable service.
You might not think they do a good job at providing these services.