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When a Spit Kit Isn’t a Spit Kit: Understanding the 23andMe FDA Warning Letter

Jordan Deatherage

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In November, the ancestry and DNA-mapping company  23andMe received an FDA Warning Letter ordering the company to cease marketing and distribution of its saliva collection kit. The recent media darling, and likewise many of its fans, seemed surprised the government would want to regulate a “spit kit.” But according to the FDA, the implications of this simple kit — or “medical device,” as the FDA would classify it — are far-reaching and require more oversight.

23andMe was cofounded by Anne Wojcicki in 2006 and received financial assistance from Google, since, at the time, Wojcicki was married to Google founder, Sergey Brin. Since then, 23andMe has positioned itself as a DNA company that puts important family health history directly in the hands of consumers. The company claims their analysis of each person’s DNA, derived via the spit kit filled at home then mailed in, helps consumers learn if they’re at risk for conditions like breast cancer, sarcoma, type 2 diabetes or Parkinson’s. Interestingly, the 23andMe patient data pool has become one of the largest sources of private Parkinson’s genetic research, gathered in a fraction of the time an approved medical research effort could have done it.  

However, these revealing and specific results are exactly the reason the FDA wishes to classify and regulate the 23andMe spit kit as a medical device. It’s not because the spit kit itself is complex, but rather because of the level of detail and presumed accuracy of the report that accompanies the results. In its letter to the company, the FDA notes that false positives or negatives could “lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions” or “result in a failure to recognize an actual risk that may exist.” In short, since the kit and analysis are providing medical information but have not been fully evaluated or vetted by the FDA, there’s no way to ensure the results are accurate.

Related — and supporting the FDA’s concern — a recent study published in the journal Genetics in Medicine revealed that, despite widespread awareness of Angelina Jolie’s preventive double mastectomy, this knowledge didn’t lead to more people actually understanding how gene mutations affect breast cancer risk. In other words, arming consumers with complex and potentially powerful health information without context or scrutiny is not always in the best interest of the consumer.

The situation illustrates a growing disconnect between the expectations of the health startup community and those of the FDA, analogous to this FDA letter issued last May for an unapproved urinalysis mobile app. FDA is making it clear it expects companies — no matter what their origins — to adhere to their safety and efficacy standards.

Currently, 23andMe spit kits and DNA analyses are not available for purchase, and all advertising has ceased until the FDA issues are resolved. While the investigation rolls on, some industry voices believe this case will blow over. Others have expressed the belief that 23andMe is a progressive scapegoat in an outdated healthcare system and similar companies will pop up in its wake. Regardless of the outcome, a precedent will be set for how consumer DNA tests will be regulated  in the future, as well as the diagnostics and genetics industries overall.

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