23andMe Still Optimistic Despite FDA Warning

23andMe Still Optimistic Despite FDA Warning

December 9th, 2013 // 2:44 pm @

In November, 23AndMe, a genetic testing company by mail that has the backing of Google, got a warning letter from FDA, which ordered the company to stop selling its $99 saliva test kit. At issue were concerns about the clinical validity of the test results.

After a great deal of debate, it appeared last week that 23andMe gave into FDA. The company last Friday agreed to stop providing health results to customers who purchased the kit after Nov. 22. But these customers still could get information about their ancestry as well as raw data from the tests. That was a big give away by the company, as the kit was marketed as being able to provide information on 254 diseases and conditions.

However, the company reported this week that it is eager to clear FDA concerns and to start selling its saliva test kits again. The CEO of the company stated on their website that the company is not going anywhere, but they know that getting FDA clearance as a medical device does take time.

We do not know how long it will take the firm to be able to go back to its full services again. But the CEO of the company thinks it will happen eventually. She also noted this week that the firm may start to reintroduce parts of the health test in several stages. Some aspects of the testing service can be addressed in short order and others will take more time and effort to work through with FDA.

The CEO stated that even though 23andMe has a difficult relationship with FDA right now, the firm seems to be reaching a bit of a truce with FDA. It may be able to start marketing itself as the only FDA approved genetic testing company. It also is possible that the firm will really benefit from all of the press attention to this case.

It seems to use that 23andMe hurt its cause with all of its aggressive PR campaigns for its product. Perhaps the company spent too much on marketing and not enough on FDA compliance? But the company still has a lot of money, with several rounds of successful funding from billionaire investors in recent months.

23andMe still plans to gather genetic information from a million or more customers, and that will then be used for research and development. But FDA thinks that that is one million people who could be getting inaccurate data about their health, and then they could mistakenly act upon that. For example, 23andMe has been testing various gene mutations that show a woman may have a very high risk of breast cancer. A woman could get a false positive and then get a mastectomy when she does not need it.

The company maintains that the FDA warning letter is being misinterpreted by the media. FDA thinks that the test results might not be right because it does not have enough proof from the company yet. That does not mean that the data and proof does not exist.

What is clear at this point is that genetic testing is the wave of the future, and 23andMe is not going away.



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