DNA analysis company 23andMe has been forced to halt sales of its testing kit, after the FDA decided the saliva kit counted as a medical device and as such lacked the proper regulatory approval. The decision, which affects 23andMe's flagship "Personal Genome Service" (PGS) testing product, comes becomes the "FDA is concerned about the public health consequences of inaccurate results from the PGS device" the agency said in a warning letter, arguing that the company - which was co-founded by Anne Wojcicki, former partner of Google co-founder Sergey Brin - was putting customers' health at risk by potentially mis-diagnosing or overlooking actual medical concerns through its unapproved assessments.
"Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act" the Food and Drug Administration wrote. "Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions."
According to 23andMe's site, the PGS test is capable of identifying increased risks of diabetes, coronary heart disease, and breast cancer. Google's Brin self-identified a predisposition to Parkinson's using the kit, and indeed Google was one of the company's earliest investors.
Over-confidence in the accuracy of the 23andMe test results, however, could lead to a patient electing for unnecessary surgery, or indeed missing surgery that their actual condition demands, the government agency warns. The FDA is also concerned that users might bypass advice from their physicians having relied too greatly on the PGS results.
"For instance, if the BRCA-related 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. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care" FDA
According to the FDA, while it has contacted 23andMe on multiple occasions with concerns about the testing kits it offers, "including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications," the company did not address the issues raised. In fact, the FDA points out, 23andMe has instead increased its promotional work and seemingly intends to increase the list of potential diseases the kit tests for.
23andMe's approach to health - and the idea of democratizing genetic testing, with its $99 kit - was made more topical in recent months with the attention paid to the Google-backed Calico project. While full details of Calico are still mysterious, Google is believed to be intending to use "big data" approaches to hunt down potential treatment options for diseases, taking advantage of the rise in personal testing (and an broader range of patient types, thanks to Obamacare bringing in data from those who might not have previously been tested) to pick out the common factors of those who live longer and avoid illness.
23andMe is yet to comment on the FDA's warning. Earlier this month, the company announced it would be switching to a new "microarray chip" that will supposedly improve the speed of its disease and genetic history testing, among other things.