Print“Most of the intended uses for Personal Genome Service listed on your website, a list that has grown over time, are medical device uses, the FDA writes. ”
The U.S. Food and Drug Administration sent a letter to genetic testing company 23andMe warning it to stop marketing its direct-to-consumer genetic test until it receives the agency’s authorization.
The FDA said the company’s Saliva Detection Kit and Personal Genome Service falls under the definition of a device because it provides diagnostic information and as such, requires premarket approval.
While the Google-backed company is careful not to classify its service as a diagnostic, the FDA called it to task for numerous marketing claims, such as providing “health reports on 260 diseases and conditions,” identifying a person’s response to certain drugs and risk for diseases, and using the information to take “steps toward mitigating serious diseases.”
“Most of the intended uses for Personal Genome Service listed on your website, a list that has grown over time, are medical device uses,” the agency writes. “Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.”
The FDA expressed alarm over some of the intended uses of 23andMe’s test, such as assessments for BRCA-related genetic risk and drug responses. Inaccurate results such as false positives or false negatives could lead to potential health consequences in the case of serious diseases such as breast cancer or people deciding to self-manage treatment based on unverified results.
“The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients, or if incorrect test results are reported,” the FDA writes.
The FDA is also frustrated by 23andMe’s unresponsiveness to numerous attempts to help the company gain compliance for its DTC test. Since 2009, the agency has worked to set up protocols and help the company determine the classification for certain uses. In July and September 2012, 23andMe submitted 510(k) applications for several indications for its DTC test but it didn’t follow up with information requested by the agency.
In January 2013, 23andMe told the FDA that it was “completing the additional analytical and clinical validations for the tests that have been submitted” and was “planning extensive labeling studies that will take several months to complete.”
The agency has yet to see any new data assuring the firm has analytically or clinically validated the Personal Genome Service for its intended uses and hadn’t heard anything from 23andMe since May. But during those months of silence, 23andMe initiated new marketing campaigns, including television commercials that showed it was planning expanded uses of its service and increasing its consumer base without obtaining marketing authorization.
23andMe acknowledged that it had received the FDA’s letter and said it was “committed to fully engaging with them to address their concerns.” But it hasn’t stopped selling its service and adding to its consumer base.
December 01, 2013
http://www.burrillreport.com/article-fda_warns_23andme_to_stop_selling_its_dna_tests.html
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