Friday, 26 May, 2017

FDA Approves Marketing Of Consumer Genetic Tests For Some Conditions

First Consumer Genetic Health Risk Test Gets FDA Approval FDA OKs 1st At-Home Genetic Tests for 10 Disorders
Sammy Stanley | 08 April, 2017, 01:20

On Thursday, the FDA gave 23andMe permission to market its Personal Genome Service genetic health risk tests for 10 diseases. "Consumers can now have direct access to certain genetic risk information", said Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health. However, the U.S. FDA has reiterated that the tests are not to be taken as conclusive of determining the overall risk of developing a disease or a genetic disorder, since genetic risk stands as one part of the large puzzle in disease diagnostics. Additional research confirms this information can be identified from a saliva sample. The tests can not be used to actually diagnose disease. For $200, you can get a kit, put in a saliva sample, send it back and you'll receive the results that will tell you if there's a possibility that you can get these two diseases plus eight others.

While some have welcomed the FDA approval, others are wary of direct-to-consumer genetic testing. In some cases, patients also have to visit a genetic counselor before doing a genetic test. What are you going to do with this information?

And it isn't clear what consumers should do with their newly calculated disease risk, especially for conditions like Alzheimer's for which there isn't a cure or even a course of action to prevent the disease. "It does not mean they will or won't ultimately develop a disease", he added.

The FDA did warn that the tests could yield false-positive results, indicating incorrectly that a person has a certain genetic variant that would increase risk of a particular disease or condition.

They also expressed concern that people would start taking "morbidity inducing actions", (like risky procedures they didn't actually need), based on their results.

One major advantage of at-home DNA test will be that it can dispense with the practice of consulting a medical professional for a genetic test.

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