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FDA Orders 23andMe to Halt Sales of Genetic Test

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Jarod Cassidy4 years ago

23andMe Inc has announced that it will be halting sales of its health-based genetic tests while the U.S. Food and Drug Administration conducts a regulatory review of the products.

FDA Issues Warning over 23andMe Genetic Tests

  • According to Modern Healthcare, he FDA is currently conducting a review of 23andMe’s health-related genetic tests and has filed a class action lawsuit.
  • Originally launched five years ago, the company claims that the saliva-based tests can inform patients if they are at risk of over 250 diseases as well as be used to provide information on ancestry.
  • The FDA, however, has ordered that 23andMe stop marketing the tests stating that only government approved medical tests can make such claims. As of yet, 23andMe has failed to provide sufficient evidence that the product has been clinically validated.
  • The FDA has warned that 23andMe’s genetic tests could result in patients seeking erroneous or ineffective medical care.

23andMe to Follow FDA Order

  • 23andMe announced Thursday that it would continue to provide ancestry information and raw genetic data to customers through the review.
  • However, the company will not be allowed to provide any medical interpretation or advice based on the data provided.
  • Customers who purchased the test after the last month's FDA order will be eligible for a refund.
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