23andMe digs in as FDA demands tests come off the market

23andMe CEO Anne Wojcicki

Now that the FDA has fired off a strongly worded rebuke of its Personal Genome Service, 23andMe is standing by the accuracy of its unapproved test, promising to work with regulators but giving no indication that it'll stop selling its sole product.

In a Tuesday blog post, 23andMe CEO Anne Wojcicki was at once contrite and strident, acknowledging her company's failure to follow through on regulatory protocols but suggesting the FDA ought to meet 23andMe halfway. To date, the company has not specifically addressed the FDA's demand that it stop marketing PGS.

After the FDA's harangue, Wojcicki stopped short of a defiant tone, writing that the company has worked extensively with its CLIA-certified lab partner to validate PGS results and stands by the results of every test, "but we recognize that the FDA needs to be convinced of the quality of our data as well." In its warning letter, the agency was incensed after 23andMe ignored it for 6 months, failing to respond to various communications after filing for clearance in 2012. Wojcicki doesn't dispute the timeline, acknowledging that 23andMe received agency feedback but has simply fallen "behind schedule" with its responses.

The FDA's take on PGS is simple: 23andMe's product is a medical device that provides diagnostic information and must thus go through the regulatory rigors required of all such products. Wojcicki, however, considers PGS part of a newfangled class of offerings that empower patients to better understand their own bodies, suggesting it deserves a path to market all its own.

"This is new territory for both 23andMe and the FDA," she wrote. "This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public's safety."

23andMe is careful never to describe PGS as a "diagnostic," saying instead that the test is "intended for research and educational purposes." The FDA remains doubtful as to whether that distinction is clear to patients, and the agency worries that un-vetted PGS results may spur elective surgeries, altered drug regimens or other risky health decisions, with test-takers betting their lives on a process the agency hasn't approved.

Since its launch in 2007, PGS has earned 23andMe some fervent consumer boosters, many of whom have taken to social networks to decry the FDA's scorn. However, some may be doing more harm than good, including the roughly 2,400 signatories of a WhiteHouse.gov petition to "overrule the FDA's decision to bar 23andMe from selling their potentially life-saving diagnostic kits."

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