FDA Approves Marketing Of Consumer Genetic Tests For Some Conditions

08 April, 2017, 00:29 | Author: Joy Garcia
  • US FDA allows 23andMe to sell genetic tests for 10 diseases

"Consumers can now have direct access to certain genetic risk information", said Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health.

The U.S. Food and Drug Administration on Thursday agreed to allow genetic testing company 23andMe to market tests directly to consumers to assess their predisposition to develop 10 diseases, including Parkinson's, Alzheimer's and Celiac disease.

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. But it cautioned that genetic risk is just one piece of information and does not mean they will or won't eventually get a disease. In addition, this may nudge them to make key changes in their lifestyle choices to minimize the incidence of these diseases.

The FDA said the authorization came after reviewing data from the company's tests and peer-reviewed literature that demonstrated the GHR tests "correctly and consistently identified variants associated with the 10 indicated conditions or diseases from a saliva sample". However, these new allowances in the genetic testing market do not include GHR tests that function as diagnostic tests.

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Thrombophilia (hereditary); a blood clot disorder. Apart from certain genetic variants, various environmental and lifestyle factors may be equally crucial in causing disease conditions. The agency also established criteria known as special controls clarifying its expectations for assuring the tests' accuracy and reliability.

The genetic health risk (GHR) tests are available from the 23andMe personal Genome Service.

In November 2013, the FDA blocked 23andMe from marketing its GHRs, citing a false positive result could lead to unnecessary treatments, while a false negative could lead a patient to improperly treat an actual risk that may exist.

Users of these tests should consult a health care professional with questions or concerns about results, the FDA said.

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