The U.S. Food and Drug Administration (FDA) is seeking to stop all sales and marketing of a DNA testing product that appears to be more of a medical device than a consumer product. The FDA is seeking to stop consumer sales of 23andMe’s genetic testing products until approval is obtained.
The agency says it has yet to receive sufficient evidence that the company’s Personal Genome Service (PGS) provides accurate results.
According to the FDA’s warning letter, 23andMe did not provide the agency with appropriate evidence that PGS delivered accurate results. According to a The New York Times report, the agency wrote that it is concerned about the public health consequences of inaccurate results from the PGS device.
Google-backed 23andMe is one of the more popular genome testing firms. The company is run by Anne Wojcicki, the wife of a Google founder, Sergey Brin, from whom she is now separated. The test, which was priced at $99, is only available on the 23andMe website. Some 500,000 people have used the test, which uses a saliva sample to analyze one’s DNA. The analysis advises consumers about a number of items, including their increased or decreased risk of developing a number of diseases.
23andMe’s DNA Testing Kit: Medical Device or Consumer Product
23andMe has been criticized for its DNA testing products and services, which some believe is a better fit in the medical world, with physicians working with it. Wojcicki asserts that consumers have the right to receive information about their own DNA; however, since 2009, the company has been meeting with the FDA about how its tests could receive agency approval.
According to the FDA, it has not heard from 23andMe since May. “Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA,” it said in the letter. 23andMe has 15 business days from the date of the letter to respond.
Most of the uses for the PGS, according to a Bloomberg report, are considered to be in the medical device category, which requires agency approval. In fact, 23andMe’s testing is meant to better enable consumers to assess their risks for a number of diseases, including life threatening diseases, such as cancer and cardiac disease.
Efficacy, Health Impact of Unregulated DNA Testing Remains an Issue
The agency is concerned with “the public health consequences of inaccurate results from the PGS device.” The agency also noted that “the main purpose of compliance with the FDA’s regulatory requirements is to ensure that the tests work.” In its letter, the agency noted that all of the work it has attempted to conduct with 23andMe has not resulted in any concrete resolution. This, despite 14 face-to-face teleconference meetings and what the agency described as hundreds of email exchanges. The FDA indicated that it has provided 23andMe with feedback on study protocols, regulatory mandates, and statistical information.
At issue are concerns about the impacts to consumers regarding the product’s efficacy. For example, if a test result is incorrect, a consumer might wrongly believe they are at risk for a disease and undergo prophylactic treatment to prevent that disease. Consider breast cancer and the related BRCA gene testing. In other cases, should a consumer be wrongly advised that he or she is not at risk for a disease, that consumer could potentially skip certain tests that are needed for early diagnosis and treatment. In other cases, incorrect testing results could lead to issues regarding dosing and other treatment options.
Because of this, the agency, in 2010, indicated that any service claiming to evaluate for risk of disease must undergo regulatory approval before that product is able to be sold to consumers. While most FDA-cleared genetic tests test for one disease, 23andMe’s would be the first to provide test information on a number of conditions.
For its part, 23andMe spokeswoman, Catherine Afarian, wrote in an email that, “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.”
The agency, in its letter to 23andMe maintains that the 23andMe Saliva Collection Kit and PGS have been sold to consumers “without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).”
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