Not Hair Loss News – FDA Halts 23andMe’s DNA Testing Service
Snippet from the article:
23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.â€
The Saliva Collection Kit and Personal Genome Service, or PGS, tells users whether they carry a disease, are at risk of a disease and would respond to a drug. Most of the uses fall into the category of a medical device and require Food and Drug Administration approval, the agency told the Mountain View, California-based company in a Nov. 22 letter made public today.
Read the rest — FDA Tells Google-Backed 23andMe to Halt DNA Test Service
I subscribe to this service and such an action by the FDA is very disappointing. This is an inexpensive service ($200) that allows you to look at your genome and compare it to others with various diseases and genetic traits. Most of my family uses it, and it gives us the security that only good data can provide.
I’m surprised you are annoyed actually Dr. The FDA has said they have had 14 face to face meetings with this company explaining how they can gather evidence and earn a license and they have done nothing and provided no assurance that their tests even work at all – let alone whether this simplistic genetic determinism is a reality (most biological researchers don’t subscribe to a one gene equals one disease in all but the rarest disorders).
This company has declared massive profits that grow each year and yet has not spent a single dime on producing evidence that their tests have any degree of accuracy (various non profit genetic research groups have dismissed their tests by the way). When people take profit over evidence and refuse to deal with the FDA you normally call them out as snake oil salesmen.
A number of researchers have raised serious concerns about these genetic test kits and the medical advice (illegally) attached to them. They have noted the possible false positive and negatives for the breast cancer gene for instance.
If someone released a hair loss test that they refused to provide evidence for and yet increased their marketing budget ten fold each year whilst ignoring increasing FDA demands to cease making claims until they conduct a verifiable study you would warn your readers not to trust them. I would be concerned – in this case they are not even offering tests and medical advice on purely cosmetic issues like hair loss. They are advising on cancer/heart disease/inherited genetic diseases – and people may receive harmful treatments they don’t need or be falsely reassured they are disease free when they are not.
I don’t always agree with the FDA but in this case they have given this sham company years of the benefit of the doubt and their action now is justified.
A thoughtful editorial in The Economist, a well-respected magazine:
http://www.economist.com/news/business/21590941-regulator-brings-genetics-company-halt-and-fda
The company seems to acknowledge that they are behind schedule in providing regulators with data on the accuracy of their tests, a function that is required of any diagnostic or therapeutic that can alter a consumers behavior due to the results.