US regulators have ordered 23andMe Inc., the DNA analysis company co-founded by Anne Wojcicki and backed by Google, to halt sales of its "spit kits" and home DNA testing kits because they're being sold without “marketing clearance or approval.” [Bloomberg]
Here is the stern letter Wojicki received from the FDA. [WSJ]
The FDA said some of the intended uses of the company's Saliva Collection Kit and Personal Genome Service (PGS) are particularly concerning, including risk assessments for certain cancers. The agency said that if the company's risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo preventative surgery, intensive screening or other potentially risky procedures. A false negative, on the other hand, could result in a failure to recognize actual risk.
Disclosure: I am a cancer patient. I have used a complimentary trial version of their service, and found it interesting. I did not rely on the results alone for medical advice. The genetic tests for cancer I took were ordered by doctors at my hospital, and performed by Myriad Genetics, which at the time held a monopoly on the most common tests. I have always considered 23andme to be a provocative kind of experiment, and a source for questions for my doctors, or followup testing with my doctors-- but 23andme is not the same as medical screening overseen by a doctor. I would not base decisions for surgery or chemo on the results of the 23andme spit kit alone, and I can't imagine any sensible patient or doctor doing so. The service explicitly tells users not to make medical decisions based on test results, if I recall correctly.
Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration.
And in the WaPo, Timothy B. Lee, who believes the feds should leave 23andMe alone:
Having more information about your health status is never dangerous by itself. It only becomes dangerous if patients use it to make dangerous medical decisions.