Earlier this year, I purchased my mother a DNA kit from 23andMe, the genetic-testing company. I thought she’d be intrigued by the product, which enables average consumers to gain insight into their personal genomes, providing them with fascinating data on inherited conditions, genetic health risks, and ancestry information. My mom was skeptical about its efficacy from the start. She hasn't returned her test kit, and now, like other 23andMe customers caught in limbo with unused kits, she might never be able to.
On Nov. 25, The U.S. Food and Drug Administration ordered the company to cease marketing its testing kit. In a public letter, the FDA's Alberto Gutierrez posed concerning scenarios involving unneeded medical procedures and false-positive results from 23andMe's Personal Genome Service (PGS). He wrote: "[The] FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work." He went on to spell out how the company's direct-to-consumer business model could lead its customers to "self-manage," raising "serious concerns…if test results are not adequately understood by patients or if incorrect test results are reported." For example, the FDA said, 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."
As outlined in our recent cover story on the Google-backed startup, 23andMe could be a disruptive force in the health care and insurance industries. For only $99, consumers could purchase a 23andMe "spit kit," which includes a plastic tube that allows them to collect a saliva sample and send it back to 23andMe’s lab, where it’s then tested for more than 240 health conditions.
But since the FDA’s order to stop marketing the company’s DNA-testing kit, 23andMe has offered little guidance to the public, other than a blog post written by CEO Anne Wojcicki promising to address the FDA’s concerns. San Diego resident Lisa Casey filed a lawsuit in the U.S. district court of California in late November claiming the company misled customers about the accuracy of tests; and only this week, 23andMe decided to cease all marketing of its gene testing, as demanded by the FDA’s warning.
Meanwhile, confusion only grows for 23andMe customers (including me and my mom), stuck in limbo between their potential genetic future and a $99 refund. What if these customers were to now mail in their saliva samples? Does the FDA’s stop order retroactively include a halt to returning results to customers who have already paid for the kit? And for that matter, what about customers who mailed in their DNA kits before the FDA’s stop order, but have yet to have their results processed? Will those results be used by 23andMe or destroyed?
From a business standpoint, does 23andMe's decision to halt marketing of the kit amount to compliance with the FDA procedure, or are they saving their ammo for a larger fight?
A company spokesperson would only say, "Our response to the FDA is in progress. I can't comment any further than what we've already stated on our blog and in our communications directly to customers."
Fast Company raised many of these concerns with 23andMe’s customer service representatives. They first returned an automated answer, addressing none of these problems. After a more specific follow-up—does this mean that results won't be returned, or worse, that results shouldn't be trusted?—the company responded, days later, replying only, "This is in response to your questions regarding the FDA letter and how it will impact our service. We are still working on getting answers to your questions, as well as questions from many other customers about the implications of the FDA letter…. However, many of your specific questions remain unanswered."
It’s a thorny issue. But should it be so unexpected for a company whose business model is built on the idea of offering a glimpse into the future?
In her first interview since the debacle began, on Tuesday, Anne Wojcicki acknowledged, "We failed to communicate proactively."