23andMe, the genetic testing company, has bowed down to the pressure from the U.S. Food and Drug Administration (FDA), saying that it will stop issuing any health reports.
The company's Saliva Collection Kit and Personal Genome Service (PGS) allows a user to get important information regarding ancestral origins, any disease they are carrying, if they are at any risk of disease or an illness and how they would respond to a drug.
The FDA had already raised concerns and has also issued a warning letter to the company on November 22. The company has been asked to stop its marketing and advertising of its products after it was hit by a class-action lawsuit that claims the company makes false and misleading statements about its testing services to provide relevant genetic information about medical conditions.
The agency has also asked 23andMe from providing any health-related genetics tests while the agency is reviewing them.
"After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review," said Anne Wojcicki, co-founder and CEO of 23andMe. "I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future. Our goal is to work cooperatively with the FDA to provide that opportunity."
Details on the changes to our health-related product. How do they impact you? http://t.co/HzmsQj8vrq
— 23andMe (@23andMe) December 6, 2013
Here's the official 23andMe press release regarding our discussions with the FDA: http://t.co/6YDqcD5JRt — 23andMe (@23andMe) December 6, 2013
One of the key concerns pointed out by the FDA was that the results may cause consumers to make difficult as well as life-changing decisions on high-risk health issues. The FDA also worries that the test results may tempt customers to self-medicate or change their medicine dosage without consulting a doctor.
Market observers also say that people who submitted their samples to 23andMe also sign away the rights to their personal genetic data, which allows the company to share sensitive data with other companies. Customers can then get targeted by insurance and pharmaceutical companies that may know a person's medical conditions. However, 23andMe suggests that it does not sell a customer's information without their explicit consent.
23andMe confirmed that customers who purchased the test before November 22 will have access to their health-related information from the company. However, customers who ordered the test on or after November 22 will be eligible for a refund.