Will 23andMe Survive an FDA Warning Letter?
December 4th, 2013 // 4:01 pm @ jmpickett
It has been only a week since FDA hammered 23andMe, a personal genetics testing service. The future of the firm is still cloudy. According to FDA, the firm has only 15 business days to show FDA that it is in compliance on its marketing of its genetic testing devices. It was accused by FDA of overpromising on the results of its test kit, including learning whether or not you have a chance of getting some forms of cancer.
We do not know if the company is going to be able to keep selling its saliva test kits for $99 each. But the ramifications of the FDA blast are obvious.
This week, the company stated that it is no longer marketing the product. Some people see the warning given to 23andMe as wrong. According to the cofounder of the genome research project SNPedia, the FDA move is silly, and is like banning scales because they could be inaccurate in some cases.
However, others say that 23andMe has not done a good enough job of working with FDA. The company has existed for six years, and have a lot of time and money to get the proper approvals for its product.One of the possible reasons is that the company simply could not support the claims it made about its tests. FDA wanted to see that there was strong evidence that users could be led to better medical results and outcomes. According to some experts, there is a good chance that all of the genomes that were tested by 23andMe probably had at least a single error, which would be enough for FDA to step in.
It was reported that each of the nucleotide tests in the saliva kit are accurate, with an error rate of 1 in 7000. But the process used by the company tests thousands of the nucleotides, so there is a good chance that at least one would be wrong.
The likely outcome is that the company will no longer promote itself as a medical device, and will promote itself as just a regular service. This will involve it making much more modest claims about its services and its marketing will be a lot less aggressive. But there still is a chance that it could continue to get the attention of FDA; other genetic testing companies have been flagged by FDA in recent years.
