Genetic testing company 23andMe is the recipient of a 22 November 2013 Warning Letter from the US Food and Drug Administration (FDA) for allegedly marketing its products without proper federal approval, regulators said today.
The company offers a direct-to-consumer genetic testing product which is used to analyze and predict a person's likelihood of eventually developing various health conditions or traits.
FDA, however, contends the company's Saliva Collection Kit and Personal Genome Service (PGS) is a medical device under the Federal Food, Drug and Cosmetic Act (FD&C Act) and, having not obtained FDA approval or clearance, is misbranded under the law.
The company's marketing of the device as a way to obtain information on "254 diseases and conditions" and a person's "carrier status," "health risks" and "drug response" were all flagged by FDA as being improper for an unapproved or un-cleared medical device. Also flagged were claims that the information could be used to "take steps toward mitigating serious diseases," such as diabetes, heart disease and breast cancer.
"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these," FDA explained in its letter.
Regulators said a false-positive could result in unnecessary surgery and "other morbidity-inducing actions," while false-negative results could lead to a patient being less proactive about screening for risks.
While FDA said the company had submitted premarket notification applications, otherwise known as 510(k) applications, it said the company had not yet been cleared for marketing because of unresolved deficiencies in its applications. Those applications were, as a result of the deficiencies going unaddressed, withdrawn by FDA.
"To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. § 360(k)," FDA wrote.
Regulators said the company's marketing of the device was concerning given the attempts by 23andMe to obtain a 510(k) and, reportedly, 14 face-to-face meetings, "hundreds of email exchanges" and "dozens" of written communications.
"[E]ven after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions," it wrote.
Regulators said the company should immediately stop marketing the PGS device until it has obtained marketing approval or clearance from FDA. 23andMe has 15 days in which to respond to FDA's concerns.
FDA Warning Letter to 23andMe