Companies in the in vitro diagnostic and mobile medical application industries should carefully review a recent warning letter from the U.S. Food and Drug Administration (FDA) that demands 23andMe, a personal genomics company, to stop marketing its Saliva Collection Kit and Personal Genome Service (PGS).

On November 22, 2013, the U.S. Food and Drug Administration (FDA) issued a warning letter to 23andMe notifying the company it was in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act) for marketing PGS without premarket clearance or approval. In the letter, FDA stated that 23andMe’s website was marketing PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease and breast cancer.

FDA highlighted some of the PGS’s marketed indications as “particularly concerning” due to “the risk that a direct-to-consumer test result may be used by a patient to self-manage,” particularly where “test results are not adequately understood by patients or if incorrect test results are reported.” In particular, FDA pointed to “assessments for BRCA-related genetic risk [detecting breast cancer susceptibility] and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these.” FDA suggested false positives for genetic risk of breast or ovarian cancer could lead to a patient undergoing “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.” With regards to results about drug responses, FDA expressed concern that patients relying on such results may try “to self-manage their treatments through dose changes or even abandon certain therapies.”

The warning letter illustrates the difficulty of marketing diagnostic tests to users who are not medical professionals, but it also provides insight on FDA’s assessment of risk for certain types of diagnostic tests. Michael Best & Friedrich LLP has attorneys who are knowledgeable about these issues and can help companies assess their product offerings and marketing materials for regulatory compliance. Read the warning letter here.