Its aggressive marketing campaign has caused skepticism from the FDA about its accuracy - and the claims the company was making made sound a lot like a medical device. 23andMe probably wanted to avoid that kind of approval process, since it takes years but stonewalling the FDA likely did not help.
Now the company says it would only provide ancestry information and raw health data.
Here are the details in their statement:
"If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results."
"I understand that 23andMe only sells ancestry reports and raw genetic data at this time. I understand 23andMe will not provide health-related reports. However, 23andMe may provide health-related results in the future, dependent upon FDA marketing authorization."
FDA approval is not a short process in the best of circumstances. Due to concern that inaccurate results, false negatives or positives might encourage patients to treat themselves for diseases they don't actually have — or to medicate improperly, leading to potentially fatal results, this could take a long, long time.
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- The Problem For 23andMe And The FDA: People Don't Understand Genetic Test Results Or Their Implications