By Bio-IT World Staff
December 6, 2013 | It appears the first chapter in the recent saga of 23andMe and FDA is now coming to a close, as 23andMe at last caves to regulatory pressure and suspends all sales of its health-related genetic tests.
An open letter from CEO Anne Wojcicki, posted last night on the 23andMe blog, reports that "23andMe will comply with FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review processes." A similar message now greets customers on the front page of 23andMe's website, along with an assurance that older customers will still have access to their full health results. This action follows two weeks of intense speculation in the wake of a November 22 letter from FDA to 23andMe, ordering that the company "must immediately discontinue marketing the PGS [Personal Genome Service] until such time as it receives FDA marketing authorization for the device."
23andMe's commercial strategy was always courting regulatory intervention, as no clear standards were in place in 2006, when the company was founded, outlining whether the federal government would have a role in vetting direct-to-consumer (DTC) genetic tests for susceptibility to health conditions. One camp has held that an individual's personal genetic information should be freely accessible, that genetic testing is fundamentally distinct from the tests "intended for use in the diagnosis of disease or other conditions" that FDA has traditionally covered, and that the 23andMe consumers belong to a unique class of genetic enthusiasts who know enough to take their health reports with a grain of salt. 23andMe has seemed to hold with this train of thought, operating out of a CLIA-approved lab to offer some regulatory assurance of the validity of its raw genetic reads, but declining to submit its gene-disease association data for validation.
Another camp has insisted that federal agencies have a vital role to play in these DTC tests, because the average consumer has no way to independently verify any health reports made on the basis of her genetic information, and the go-between companies that deliver these interpretations must be held to some medical standards. This is clearly the role that FDA sees itself filling in the future of personal genetic testing.
As the controversy reached a boiling point in the wake of the cease-and-desist letter, one aspect of the disagreement that provoked a great deal of comment was 23andMe's apparent open defiance of FDA. The agency's letter asserted that "FDA has not received any communication from 23andMe since May," despite repeated requests for information on how the company produces and validates its health reports. Even defenders of 23andMe's business strategy and right to operate have seemed at a loss to account for this behavior.
Now it appears that the channels have been reopened. Ms. Wojcicki's open letter to her customers references "discussion with officials from the Food and Drug Administration today," and the removal of health testing from 23andMe's services could be seen as a tacit admission that 23andMe does not see its position as strong enough to challenge the agency's directive in the courts.
Until the announcement yesterday, 23andMe has tried to thread the needle of literal compliance with the "discontinue marketing" directive by withdrawing its advertising, while sales of the PGS remained open online. Just in time for the 15-day deadline set by FDA, however, the company has dropped this distinction. With its health tests withdrawn from the market, 23andMe can only offer raw genetic reads and ancestry reports, removing its crucial distinction from other services like Ancestry.com or National Geographic's Genographic Project, all of which either buckled earlier to the regulatory hazards of offering genetic health information, or declined to enter the arena altogether.
Customers who received health reports from 23andMe before the date of the FDA letter will still have access to those files, but all new customers from November 22 onward will be kept in the dark about what their genetic data says about their health, at least until such time as 23andMe receives FDA clearance for some or all of its health reports. Any customers who ordered the PGS between November 22 and last night's announcement will be offered a full refund if they desire one.
On the other hand, Wojcicki reaffirmed 23andMe's commitment to leveraging the massive database it has collected – including genetic information from over half a million individuals – toward new health discoveries. "We will continue our Parkinson’s, sarcoma, MPN and African American research projects," she writes, "and plan to launch more communities in 2014."
The imbroglio now appears set to enter a tamer, more drawn-out phase, as FDA and 23andMe work out the precise boundaries of regulatory oversight for DTC genetic testing. Proponents of open access to genetic health data must hope that the bar is set somewhere below the level of accuracy required for standard clinical tests, as genetic data simply cannot support clinical levels of validation for most conditions for the foreseeable future. A possible compromise that admits FDA oversight of 23andMe's data, but allows some flexibility in the degree of validation required in return for strong disclaimers about the quality of genetic health information, may be the fastest and most realistic path toward the return of a renewed PGS with at least some health reporting intact.
23andMe Attracts Class Action
23andMe: State of the Debate
FDA to 23andMe: Stop Marketing Kits Immediately