23andMe DNA testing kit. Photo from 23andme.com.
Last year, I participated in The Genographic Project, a DNA testing that identifies genetic ancestry. Much has been written about the perils of genetic testing, but the project has a scientific purpose and handles DNA results with appropriate privacy. I still recommend it to people.
Three months ago I became interested in 23andMe‘s DNA testing service. In addition to providing ancestry results, the test also included medical data on genes that could possibly cause health problems.
Having recently watched my grandmother decline from dementia, I began research on 23andMe. I encountered a few articles regarding privacy and accuracy concerns, but it appeared that if I discussed the results with my doctor, the test would be beneficial. I ordered a kit for $99.
I didn’t register the kit immediately after receiving it. I figured I would do it later. In retrospect, my procrastination may have been a good move.
FDA gets involved
On November 22, the FDA issued a warning to the company concerning the medical aspects of the test. It asked the company to stop selling the test. Apparently, 23andMe had ignored FDA requests for information about the service as far back as 2012. According to media reports, even the company’s founders acknowledge there was a lack of communication with the FDA. Still, testing kits continued to be sold while the company touted the medical benefits.
Flash forward to Dec. 6. and the company has now stopped selling the kits.
If I hadn’t being paying attention to the news, I would have not known about the situation. The company did respond to the FDA’s letter on a blog post, but I did not receive an e-mail about the situation until today. There’s more detail on the company’s blog.
Mistakes we made
As I mentioned to the company on Twitter and Facebook, this whole situation has given me pause to go forward with the testing. Here’s why:
- 23andme ignored FDA requests for a substantial period of time.
- The company continued to market the kits after November 22.
- It appears that 23andme hadn’t anticipated FDA scrutiny and action.
Thus, I’m left questioning the trustworthiness and ethics of the company. At the very least, that’s some poor business management. I don’t want to trust them with my DNA.
People are quick to blame the FDA for the situation, but that agency appears to be doing its job. Because of 23andme’s refund policy, I’m out $99. I chalk that up to a lesson learned.
I hope 23andme gets things worked out with the FDA. I see value in the service. Genetic testing can be helpful if you are comfortable with your DNA fingerprint being on file and you consult a medical professional to interpret the results.
Genetic testing does raise valid concerns regarding accuracy, trust and privacy. 23andme’s recent missteps will not help to alleviate them.