Tags: 23andme | genetic disease test | fda

23andMe Genetic Disease Test Kit OK'd by FDA

Image: 23andMe Genetic Disease Test Kit OK'd by FDA

The FDA approved 23andMe to sell genetic disease testing kits. (Associated Press)

By    |   Friday, 07 Apr 2017 05:23 PM

Biotech firm 23andMe has received Food and Drug Administration approval for the first direct-to-consumer testing for genetic disease markers that could tell people the likelihood that they will develop 10 different health conditions.

The approval is a reversal from a 2013 FDA moratorium that prevented Mountain View, California-based 23andMe from selling the disease tests. Following this ruling, other companies are expected to seek approval to sell the tests as well, according to The New York Times.

Most of the disease markers tested by 23andMe are for rare diseases, including factor XI deficiency and celiac disease, but consumers can also request information about risk genes for Alzheimer’s and Parkinson’s if they want that information, The New York Times reported. Genetic counselors are available for those who aren’t sure whether they want to be tested, although counseling comes at an additional cost.

The tests are conducted by extracting DNA from saliva samples and testing it with a special genotyping chip. Results are available online in six to eight weeks. Four genetic disease markers are included in the test currently available, with more scheduled to be rolled out in the near future, according to The Wall Street Journal.

23andMe also uses data from customers to gain information that could possibly lead to new treatments and medications, the WSJ reported. To gain approval, the company had to demonstrate that the tests were highly precise and that consumers would be able to understand and use the information in results.

The FDA has directed 23andMe to label their product to show that it “is not intended to diagnose a disease, determine medical treatment, or tell the user anything about their current state of health,” The Wall Street Journal reported.

Reaction by Twitter users was mostly positive toward the tests.

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Biotech firm 23andMe has received FDA approval for the first direct-to-consumer testing for genetic disease markers that could tell people the likelihood that they will develop 10 different health conditions.
23andme, genetic disease test, fda
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2017-23-07
Friday, 07 Apr 2017 05:23 PM
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