FDA Orders 23andMe Inc. To Discontinue Marketing Its Personal Genome Service


In an unusually harshly worded Warning Letter, the Food and Drug Administration (FDA) ordered the genetic testing company, 23andMe Inc., to immediately discontinue marketing its saliva collection kit and personal genome service (PGS) until the company receives FDA marketing authorization for the device because the device is adulterated and misbranded. The device is a direct-to-consumer genetic testing kit that is intended to provide "health reports on 254 diseases and conditions." As the FDA stated in the publicly available letter to the company's CEO, Anne Wojcicki (wife of Google co-founder Sergey Brin):

Some of the uses for which PGS is intended are particularly concerning...because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications...if the...risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist...Assessment responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.

The FDA comes out swinging in this letter, obviously anticipating litigation. Unlike most Warning Letters, for example, this one sounds like an advocacy brief, marshalling all of the evidence of the FDA's hard work, fairness, and concessions to the applicant, followed by its indignation at the company's disregard of its efforts:

As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies...However, even 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...

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