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FDA Approves First Ever Genetic Tests For Consumer Use

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Genetic testing isn’t an exact science. In many cases, there is limited information when it comes to finding out how a specific gene affects a person’s health. To protect the general public from falling prey to inaccuracies and false results, the US Food and Drug Administration has been preventing DNA testing companies from rolling out products that claim to tell if a person is at a genetic risk for certain diseases.

Now, that has changed. For the first time ever, the FDA has agreed to allow DNA testing company 23andMe to market its genetic tests directly to consumers, without having to go through a doctor first. These tests can validate risks for 10 diseases, including Parkinson’s disease, celiac disease and late-onset Alzheimer’s disease, Gizmodo reports.

Previously, 23andMe offered tests for over 250 conditions, but the FDA ordered a stop to these in 2013, saying that all analyses of people’s risks factors should cease until the accuracy of the tests could be verified.

The DNA tests that 23andMe now offers have not changed after the FDA directive, but the company does have restrictions on what it can tell consumers. For example, where the company once stated “health risks” and told people how to reduce these, it is now only allowed to report on whether or not a consumer has a “carrier status” for a disease. In short, 23andMe can tell if a person might pass down specific genetic variants to their children, but not if these genes can cause a condition in the individual who took the test.

One reason the FDA initially disapproved of 23andMe’s genetic tests was because it did not find enough scientific evidence to support what the company was telling consumers.

The 10 tests the FDA have approved are for conditions with strong scientific data showing clear links between genetic variants and a disease.

These then give information on a person’s genetic susceptibilities, so as to help him or her make good health and lifestyle choices.

The FDA has further announced that it has drawn up criteria for other companies that might seek approval in the future.

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