FDA warns genetic testing service to halt sales, seek formal approval

The FDA has ordered genetic testing services company 23andMe Inc. to immediately discontinue marketing its Saliva Collection Kit and Personal Genome Service without agency clearance.

In a letter to company founder and CEO Anne Wojcicki dated Nov. 22 and made public today, the FDA said most of the intended uses for the service are “medical device uses … that require premarket approval or de novo classification, as the FDA has explained to you on numerous occasions.”

The warning letter points out that the agency has been “diligently working” to help 23andMe comply with regulatory requirements, including “significant time” spent evaluating the $99 mail-order kit’s intended uses.

Some of the uses that concern the agency include assessments for BRCA-related genetic risk and drug responses “because of the potential health consequences that could result from false-positive or false-negative assessments for high-risk indications such as these.”

As an example, the FDA letter said that a BRCA-related risk assessment for breast or ovarian cancer might report a false positive, “leading a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions…”

The company has been working with the FDA since July 2009, according to the letter, including “14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications” that included specific agency feedback on study protocols, clinical validation requirements and potential regulatory pathways.

“Even after these many interactions … we still do not have any assurance that the firm has analytically or clinically validated the [service] for its intended uses,” the letter said.

The FDA, which said it has not communicated with company since May, also said it became aware that the company has initiated new marketing and TV advertising, an indication of plans to “expand the [service’s] uses and consumer base without obtaining marketing authorization….”

The company issued the following statement Monday afternoon: "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding time line 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."