After weeks of behind-the-scenes discussions with the FDA, 23andMe has just announced that it is suspending its genetic health analysis for new customers. Those of you who purchased DNA kits after November 21st will only receive the raw genetic data and ancestry analysis from 23andMe. Unfortunately, this means the utility of the company’s $ 99 DNA test is drastically reduced for the time being.
The Food and Drug Administration released a public letter last month demanding the cessation of 23andMe’s health-based analysis. Claims were made that 23andMe had not fully complied with previous requests, so the FDA was cracking down on the Mountain View-based company. In the days following the warning letter, a number of vague posts were made by 23andMe’s staff through official channels. It seemed that 23andMe was committed to working this out with the FDA, and all of this would simply blow over. As of late last night, a blog post went up from 23andMe’s CEO explaining that the resolution to this issue won’t be easy for its customers.
In the post, Anne Wojcicki goes on to explain that to comply with the FDA’s demands, 23andMe will suspend its health analysis service until further notice. Tests purchased on or after the date of the warning letter won’t receive any health analysis at all, and existing customers will not receive updates to their health results until the FDA gives approval. Of course, this drastically changes the service being provided, so a refund is being offered to new customers unhappy with the change.
Keep in mind, the goal is to bring back the health analysis in full force after receiving FDA approval. Provided that 23andMe can pass muster, all kits will be updated to include health analysis as soon as legally feasible. However, the possibility remains that the FDA will shut down this aspect of the company completely. Considering the substantial regulatory battles that 23andMe has been through before, it’s no surprise that government entities continue to view direct-to-consumer DNA testing with suspicion.
For those of you jonesing for health analysis of your 23andMe results, third-party tools are available to take care of that. Simply export your raw data, and run it through an application called Promethease. Dozens of markers are processed, and you’re left with a nice little health report at the end. Over at Stanford, a web-based tool called Interpretome is publicly accessible, and it can analyze risk for a number of diseases as well. Plenty of options are available, and your raw test results are all you need to get going. This regulatory mess is definitely a speed-bump for personal genomics, but its far from a catastrophe as long as your raw data remains available.Stuart Caie]