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FDA wants to regulate direct-to-consumer DNA tests

FDA wants to regulate direct-to-consumer DNA tests

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The FDA thinks the consumer-to-direct DNA tests are medical devices that need to be regulated. What do you think?

Finding out your biological destiny has never been so complicated. It wasn't always like that.

In 2007, back when I got my DNA tested by 23andMe, Navigenics, and deCODEme, all you had to do was harbor curiosity about your genetic makeup and actually purchase the test online. I treated the results as an experiment and therefore didn't use them to make any medical decisions.

Not surprisingly, as these companies have become more mainstream over the last couple of years, the Food and Drug Administration has become more critical of the genetic tests.

Lately, DNA testing has gotten a bad rap. My SmartPlanet colleague Deborah Gage wrote about 23andMe's recent sample mix up, which affected as many as 96 consumers. Now Congress is on the case and has requested all communication pertaining to the mistake, as well as the company's policy for handling errors and any other documentation that could reveal previous accidental swaps.

And when Pathway Genomics announced their plans to sell DNA tests at Walgreens, it certainly struck a nerve with the already-squeamish FDA -- as it should.

DNA tests aren't the same as selling a pregnancy test over-the-counter. There is no simple "yes" or "no" answer that you will receive, and the meaning of results are often much more complicated than that.

In the latest brouhaha, the FDA sent letters to the five major DNA companies — 23andMe, deCODEme, Knome, Navigenics, and Illumina — to air concerns about "medical devices" (that is, DNA tests) that it believes should be approved before they can be marketed.

Pathway Genomics was not included because a previous FDA letter made the company rethink their plan to market their tests directly to consumers.

Dan Vorhaus wrote the following about the situation at Genomics Law Report:

Supporters of the move argue that these [direct-to-consumer] products are medical in nature and require more stringent regulatory controls. Critics, including at least one of the companies receiving a letter (23andMe), fault the FDA for adopting a paternalistic stance to personal genetic information and imposing unnecessary regulatory controls.

If you look at 23andMe's Terms of Service agreement, it's not surprising they think the FDA approval is unnecessary.

It writes:

You should always seek the advice of your physician or other appropriate healthcare professional with any questions you may have regarding diagnosis, cure, treatment, mitigation, or prevention of any disease or other medical condition or impairment or the status of your health.

Basically, any information I learned through the 23andMe service was at my own risk.

Long before the debate, I took my DNA results with a grain of salt. When I went to visit the 23andMe headquarters in Mountain View, California, I asked Ann Wojcicki about my results:

Frustration over mounds of genetic information never making it out of genetic research cliques is understandable, but I had my own frustration to address. You get the best results if you are of European descent. I told the founders I was an Asian-European mix, and when I clicked on the different options on the Web site, I got conflicting results. I wanted to know why. "Research needs to go a significant step further," Wojcicki admitted. "23andMe’s goal is to advance genetics research in this area. So 12 months from now, when you’re logging on to the site every day, we hope the data is more reflective of your [ethnic] background."

Forcing companies to get FDA approval for genetic tests would, in effect, further validate them as medical tests — giving consumers the impression that the tests can diagnose disease.

The problem is that these tests were never designed to be used as medical tests in the first place. Unlike a blood test, the results of a genetic test indicate nothing concrete. Gene mutations can't absolutely predict disease outcomes.

If anything, the tests ought to come with a huge warning label on them: "Genetic risks for disease implied by the results of this test is not a replacement for the medical advice of a licensed physician."

Newsweek interviewed Alberto Gutierrez, FDA director of its Office of In Vitro Diagnostics, about why the tests are considered medical devices years after they have been sold.

Gutierrez said:

Well, the claims [made by the companies] have changed constantly. The original claims from three years ago were very, very vague. For example, the claims they’re making now for the different drugs and how they’re metabolized, those weren’t being made previously. Even some of the health claims in terms of risk of chronic disease, those just started coming online about a year ago.

In a report published last week, Andrew Pollack of the New York Times added the following:

But the letters stop short of saying the tests must be taken off the market until they are approved. Dr. Gutierrez said in an interview that it would be unfair to remove the tests from the market because the agency had not clearly told the companies that the devices needed approval.

The answer is clear: as long as these companies continue to sell their tests directly to consumers, the issue will remain a sticky one.

Should the FDA regulate this industry before personalized medicine matures?

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Boonsri Dickinson

Contributing Editor

Contributing Editor Boonsri Dickinson is a freelance journalist based in San Francisco. She has written for Discover, The Huffington Post, Forbes, Nature Biotech, Technewsdaily.com, Techstartups.com and AOL. She's currently a reporter for Business Insider. She holds degrees from the University of Florida and the University of Colorado at Boulder. Follow her on Twitter. Disclosure