FDA Moves Toward Stricter Oversight of Personal Genetic Tests

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genetic-tests-fda-oversight-orderedIn a continuing clash with the genetic test service company 23andMe over direct sales of gene analysis service to consumers, the U.S. Food and Drug Administration (FDA) is moving toward stricter oversight of such tests.

The company 23andMe markets the Personal Genome Test, which provides the user with an analysis of his/her risk for hundreds of diseases based on DNA data from a saliva sample. The analysis also includes the expected response to certain drugs. Last month, the FDA moved to ban sales of the service, which has not received FDA approval, Bloomberg News reports. The genetic test industry is growing rapidly as demand increases for tests to diagnose or determine disease risk and help make treatment decisions, especially in cancer. Geneticist James Evans of the University of North Carolina in Chapel Hill said increased regulation is needed to make sure these tests fulfill the manufacturers’ claims.

Washington multimedia artist Lynn Fellman expresses the view of those who favor direct availability of genetic tests: “I want to know my own biology; it’s my right,” Fellman said, according to Bloomberg News. “With 23andMe, I don’t have to go to the medical establishment to get this information.” But other clients say 23andMe misled them about the accuracy and validity of its test. One user filed a complaint on November 27 in federal court in San Diego seeking $5 million, saying the Personal Genome Service advertised medical claims without getting appropriate FDA authorization, Bloomberg News reports.

Last month, in a warning letter to 23andMe, the FDA expressed concern about the “public health consequences of inaccurate results from the P.G.S. device.” The agency demanded the company stop selling the test kits until it secured agency approval. The FDA also voiced its concern that “assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.”