Your genes, your data?
23andMe is a high-profile startup that offers direct-to-consumer DNA testing. Send in a little spit swab, and they provide a variety of contextual reports on inherited traits, genealogy, and possible congenital risks. Their home test – most recently priced at just $99 — received notice within Time’s Best Inventions of 2008, roughly a half-million people ordered them, the company completed a $50 million Series D round in 2012 with a number of high-profile investors. Then the future of home gene testing split asunder.
On November 22 of this year, 23andMe received a sternly worded warning from the FDA in which it was ordered to immediately stop marketing its self-testing kits. After a two-week heated debate during which the company loudly maintained that they do not perform medical diagnoses and therefore should not receive medical device regulation, the company completely reversed its stance, offering refunds to customers who ordered tests after November 22 and began limiting its service to raw genetic information while submitting to the FDA approval process. Their recently launched national television advertising campaign was yanked, Thanksgiving was equal parts crow and turkey, and just to rub it in, a class action lawsuit was filed in California shortly thereafter.
In many ways, the battle is ample evidence of the relative speed of technology (fast) and regulation (slow), as consumer health startups look to empower individuals with personal health data while regulators try to protect people from making potentially serious health decisions with incomplete information and no medical supervision. “If you scare somebody into believing they’re high risk, they could take actions that hurt their health,” says FDA Director Alberto Gutierrez, who adds “People have every right to get their data. We want to make sure they can trust what they’re being told about it, too.”
True enough, but in an era in which consumers can buy home pregnancy and HIV tests in drugstores, view ads for prescription medication, and wade through volumes of medical information online, the imbalance seems particularly glaring. Proponents of 23andMe believe that the benefits of information, even if incomplete, outweighs the risks. And at least one columnist points out that the same government that believes genetic information is too risky for individuals to procure for themselves also routinely advises its citizens to play the State-sponsored lottery. Whether the FDA’s concerns are prudent or overly protective remain to be seen, and no test, genetic or otherwise, can predict if individual consumers will come out on top.