FDA OKs 1st At-Home Genetic Tests for 10 Disorders

Posted April 08, 2017

With GHRs, a person can bypass their doctor and test their predisposition to develop certain medical diseases or conditions without obtaining a prescription.

The 23-and-me personal genome service genetic health risk test would give some information about a person's risk for 10 diseases, including Parkinson's, late-onset Alzheimer's and Celiac disease.

The tests work by isolating DNA from a saliva sample; this sample is then tested for 500,000 genetic variants.

The company said it has been working on showing the FDA that the reports are easy for customers to understand and that they meet the agency's requirements proving that they are accurate.

The agency said in approving the tests, made by 23andMe Inc.in Mountain View, Calif., it analyzed data from peer-reviewed studies that demonstrated "a link between specific genetic variants and each of the 10 health conditions".

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However, the FDA warns that the tests are not conclusive, and the results should not be used to diagnose or inform treatment decision. However, these new allowances in the genetic testing market do not include GHR tests that function as diagnostic tests.

Ross Koppel, adjunct professor of sociology at the University of Pennsylvania, sees value in the consumer tests, but he says there are also many concerns.

"The FDA has embraced innovation and has empowered people by authorizing direct access to this information". The U.S. FDA has expressed the intention to allow for a mechanism for exempting subsequent GHRs from the genetic testing company. Genetic tests used for diagnosis or to determine a preventative course of treatment-such as the BRCA test, which indicates a high risk for breast and ovarian cancer and often leads to prophylactic surgery-are excluded from this FDA approval.

Users of these tests should consult a health care professional with questions or concerns about results, the FDA said. They were also accused of selling genetic information to other sources and the scientific community, as well as failing to obtain approval from the FDA.