FDA putting the brakes on Genetic Testing Program by “23andme”

By Logan French

Would you trust a home order genetic test?

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A popular service that analyzes a person’s DNA for markers that may signify or show the potential to have medical complications in the future was served a cease and dismiss order from the Food and Drug Administration earlier last month in November.

23andme allows people to send in a sample of their blood in a predesigned test packet to have it reviewed by an accredited laboratory by scientists who look for genetic markers that show a predisposition for or a warning for 254 known diseases through their “Personal Genome Service” for a fee of $99.

The FDA stated in their order that the program has been running without their approval and therefore is a potential risk to the people who have used the service.

Without the research by and later potential approval of the FDA, 23andme customers may choose to take an unnecessary and potentially damaging risk in changing their personal medical care.

For example, a female customer may choose to have both of her breasts removed by means of a double mastectomy if her results came back that she has markers for breast cancer.

Without the FDA approval, these potentially false statements may push patients to act on news that is incorrect or false.

The FDA also added that some of the laboratories used and the scientists were not certified properly and needed to be trained immediately to prevent the risk of more damage.

Also, the tests only look for common markers that are known to man as of the time of the test and can often lead to many false positives.

Responses from 23andme were limited, but they did announce that they will be complying as fast as humanly possible to the FDA’s requests and they look forward to getting their program accredited to serve their customers in a much more satisfactory and legitimate manner.

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Categories: Health

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