FDA Stops Sales of 23 and Me Genetic Testing Kits

The U.S. Food and Drug Administration (FDA) wants a mail-in genetic testing company to stop marketing its $99 test because of fear the results may not be accurate. 23andMe Inc. is a Google-backed company that provides a genetic profile specifically about many inherited diseases. All the consumer has to do is provide a sample of spit.

Millions of users have received genetic information on 240-plus health conditions and traits, from the BRCA breast cancer gene to an atrial fibrillation risk or an inherited tendency for Alzheimer’s disease. A couple’s profile can also raise questions for those thinking of having children. The company also claims your genetic profile can reveal how you will respond to certain drugs.

On November 22, the FDA sent the company a warning letter to stop marketing the test and it asked the company to respond to requests for additional information.  The federal agency is concerned with the validity of the genetic information and that misinformation may cause a consumer to opt for a radical medical procedure such as mastectomy.

It’s doubtful an oncologist would perform a radical mastectomy based on a $99 test alone.

The head of 23andMe, Ann Woicicki, responded to the FDA warning letter. Writing in the company’s website she said they stand behind the quality of the data that is sent to customers.

Even though 23andMe has been selling its services since 2007 with no marketing clearance it finally applied with the FDA for clearance in 2012. The company admits on its website it is behind in responding to FDA requests for additional information. Specifically, the FDA wants to know how the company can provide medical advice on the diagnosis or prevention of a disease when it is not classified to do so. NPR reports the company hasn’t responded to the FDA since last May and now the agency has given it 15 days to respond.

The Human Genome Project was completed ten years ago and it is still unknown what every gene does and how a mutation might affect an individual’s risk of disease or health. CNN reports with 2,000 disorders attributed to a single gene, many diseases are more complex. Type 2 diabetes or Alzheimer’s disease may involve hundreds of genes and the function of many remain unknown.

Consumers are rallying behind the company. On its Facebook page many claim the FDA is interfering with a person’s right to information, specifically their own genetic make-up that a consumer has the right to obtain. One petition of support has collected more than 5,100 signatures, reports the Wall Street Journal. Proponents believe the information about the potential to inherit a disease might force healthier habits or spark a conversation with one’s doctor that might not occur otherwise.