Upon learning that she's a BRCA1 mutation carrier via 23andMe, 31-year-old Jill Steinberg underwent genetic counseling and had her test results confirmed before undergoing a double mastectomy.
23andMe Saved My Life, Genome Web, 10/20/10
I'm sure the Steinbergs mean well, but I don't think they understand what they've just walked into. If I were advising 23andMe (which I am not) I would be really upset about this story. You could practically hear the FDA's jaw dropping from the West Coast.
The Steinbergs seem to believe that they are providing a justification for why 23andMe should be allowed to stay on the market. In truth, I think they're doing the opposite. Their story demonstrates why such a test might be valuable... but it also demostrates why a test like this has consequences. This is not just information, this test is not just entertainment or curiosity. This information is actionable.
If 23andMe (or anyone else) believes that they have a valuable screening test for a high risk genetic mutation, they should do the appropriate development and testing and seek approval to market it for that use. Arguing that we should lower our standards or give them a pass because what they're doing is important is exactly backwards. We need this test held to high standards precisely because it is so important.
I'm glad that the Steinbergs were able to use this information, but if we really want to acknowledge what's at stake, let's make sure we're dispensing information appropriately. We should not confuse the importance of the issue with the quality of the product. When unapproved tests are allowed to linger in the market, they may greatly inhibit the development of tests that could pass FDA muster.
Tags: Advertising & Promotion, FDA, Industry, Public Statements
