The clash between the genetic test service company 23andMe and the U.S. Food and Drug Administration (FDA) over direct sale of gene analysis services to consumers signals a move toward stricter oversight of thousands of such tests.
The Personal Genome Test from 23andMe provides individuals with an analysis of their risk of hundreds of diseases based on DNA data from a saliva sample. Last month, the FDA moved to ban sales of the service, which has not received FDA clearance, Bloomberg News reports. Genetic tests are in increasing demand for the purpose of diagnosing or determining disease risk and help in making treatment decisions, especially in cancer. James Evans, a geneticist at the University of North Carolina in Chapel Hill, said increased regulation is needed to make sure these tests fulfill their claims.
Proponents of direct availability of genetic tests say, as Washington multimedia artist Lynn Fellman did, “I want to know my own biology; it’s my right,” according to Bloomberg News. “With 23andMe, I don’t have to go to the medical establishment to get this information,” Fellman said.
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 in compensation, saying the Personal Genome Service advertised medical claims without receiving appropriate FDA authorization, Bloomberg News reports.
In a warning letter sent last month to 23andMe, the FDA expressed concern about the “public health consequences of inaccurate results from the P.G.S. device.” The agency 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.”