At-home genetic test for 10 diseases gets first FDA approval

Posted April 08, 2017

The FDA has approved 23andMe Inc's direct-to-consumer genetic test for personal disease risks, according to The Wall Street Journal. The presence or absence of some of these variants is linked to an elevated risk for developing any one of the following diseases or conditions: Parkinson disease, late-onset Alzheimer disease, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, factor XI deficiency, Gaucher disease type 1, glucose-6-phosphate dehydrogenase deficiency, hereditary hemochromatosis, and hereditary thrombophilia. With GHRs, a person can bypass their doctor and test their predisposition to develop certain medical diseases or conditions without obtaining a prescription.

"Consumers can now have direct access to certain genetic risk information", Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said Thursday in an agency news release. In addition, this may nudge them to make key changes in their lifestyle choices to minimize the incidence of these diseases.

"The FDA intends to exempt additional 23andMe GHR tests from the FDA's premarket review, and GHR tests from other makers may be exempt after submitting their first premarket notification", the agency notes. As of now, genetic tests that qualify as diagnostics, are excluded from the list of tests and will need another approval by the regulatory body.

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The FDA also announced they intend to create an exemption for subsequent GHRs from the company, which would allow similar tests from other manufacturers to market their own test kits after a one-time FDA review.

To use the genetic test service of 23andMe, a person only has to spit into a tube and send it to the company where the lab will work on extracting DNA from the saliva cells and look for genetic markers using a special chip. Similarly, false-negative findings can occur where the results incorrectly indicate lack of a critical genetic variant.