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23andMe DNA Kit Blocked by FDA as 'Medical Device'

By Admin on November 25, 2013 | Last updated on March 21, 2019

The FDA has ordered DNA testing company 23andMe to stop selling its home DNA testing kits, alleging that the company made baseless claims about diagnosing disease.

23andMe's popular DNA testing kit, previously available through its website for as low as $99, is advertised as providing information about an individual's "genetic health risks."

But the U.S. Food and Drug Administration (FDA) claims the kits are "being sold illegally to diagnose diseases" and have not been given proper FDA approval for a medical device, reports NBC News.

FDA Regulation of Medical Devices

Home testing kits, even ones which can be bought over-the-counter and do not require a doctor's prescription, are regulated by the FDA as "medical devices."

Like the FDA-approved HIV rapid home-use testing kit, most home testing kits are devices which are intended for the diagnosis of disease or conditions, like HIV or pregnancy.

23andMe is a DNA testing kit which works by analyzing the DNA contained in saliva which users submit to 23andMe's labs. The 23andMe user is then notified when the DNA data has been fully processed, and he or she can then view "health reports" based on his or her DNA profile.

With the FDA even cracking down on smartphone health apps, 23andMe's service wasn't likely to escape regulation for long.

Demand to Stop Sales

In a strongly worded letter to 23andMe's CEO Ann Wojcicki, the FDA reminded the company that advertising the DNA kit's intended use as a "first step in prevention" of diseases like diabetes and cancer puts them well within the medical device classification.

And although 23andMe had already applied for clearance in 2012, the FDA was not convinced that it had approved any prior product or device which was intended for the same use as the 23andMe kit. Without such clearance, the FDA can stop the product from being sold or marketed.

The first step in being cleared to sell a medical device is to prove that a similar product has already been cleared by the FDA to be sold -- called a predicate device. The FDA claims that 23andMe has yet to provide evidence that its kit, which is advertised as screening for variants of the BRCA breast cancer gene marker, is like any other FDA-approved device on the market.

There are other gene testing companies out there, but 23andMe is the first being told to "stop marketing its test," reports NBC news.

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