The Food and Drug Administration has ordered the startup genetic testing company 23andMe to stop DNA tests for potential patient safety risks, saying the results may mislead customers.
The company's Personal Genome Service takes consumer's saliva and sequences samples in its CLIA-certified labs, and provides customers with information on gene mutations, health risks and drug responses.
But the FDA claims the company never submitted adequate data to support its claims and has continued to sell unapproved, unverified service for five years, despite multiple meetings and hundreds of emails with agency staff, FierceMedicalDevices reported on Monday. The company charges $99 for the analysis.
The FDA is concerned that customers may make major health decisions, such as prophylactic breast removal surgery, as a result of the medical device company's report on their genetic risk for breast cancer, according to MIT Technology Review.
The FDA's letter comes in the wake of the company's large marketing campaign promoting the service, according to the article. In October, a company executive told Fast Company that 23andMe wants to revolutionize healthcare by using the data it collected from the genetic tests to become the "Google of personalized healthcare," FierceHealthIT previously reported.
In response to the FDA's warning letter, the company issued a statement to MIT Technology Review, stating, "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
Genetic testing gained momentum after Angelina Jolie announced her decision to undergo a prophylactic double mastectomy after the testing to significantly reduce her risk of inherited breast cancer. Breast cancer charities have reported a four-fold surge in women asking about having their breasts removed since Jolie announced she'd had the procedure, FierceHealthcare previously reported.
To learn more:
- read the FDA letter
- here's the MIT Technology Review article