Print“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, 23andMe CEO Ann Wojcicki wrote.”
23andMe says it suspended its health-related genetic testing services for new customers and said it would work with the U.S. Food and Drug Administration to gain regulatory approval for direct-to-consumer tests.
The decision came December 5, two weeks after the agency demanded the California-based genetic testing company stop marketing its kit and service until it gained the agency’s clearance.
Although 23andMe had initiated a process to gain FDA clearance for its direct-to-consumer test in 2012, the agency had been frustrated by the company’s failure to submit analytical and clinical validation of the test’s usefulness. The FDA was concerned that patients might use inaccurate results to make treatment decisions that could lead to potentially negative health consequences.
“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," 23andMe CEO Ann Wojcicki wrote in a blog posting that accompanied its decision to stop offering health-related genetic tests. “Our goal is to work cooperatively with the FDA to provide that opportunity.”
23andMe says it will offer ancestry-related genetic tests and raw genetic data without interpretation to new customers. Those who purchased health-related tests after November 22, when the FDA issued its warning letter, are eligible for refunds. Customers who purchased the health-related kit and service before November 22 will continue to have access to health-related results.
When customers enter the website, they are asked to confirm that they understand the changes in the service before they are allowed to continue.
23andMe’s decision to change its services came just two days after a class-action lawsuit was filed in California, claiming that the company misled customers by selling tests that had not been approved by the FDA and had no real scientific value.
After the FDA warned the company, 23andMe had continued to maintain that its Personal Genome Service was not a diagnostic and was “intended for research and educational purposes only.”
The company hopes to be able to offer health-related results in the future if it gains FDA approval to do so. “We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives,” writes Wojcicki.
December 08, 2013
http://www.burrillreport.com/article-23andme_suspends_health_related_gene_tests.html
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