For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the 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. Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk 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. “However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the [test] for its intended uses.” 
 
 23andMe isn’t the only firm offering direct-to-consumer genetic testing, but it’s the largest and best known. “But when a company is providing these types of tests where they interpret the results, we need to understand that the test actually works and the information they provide is correct.
– The FDA has ordered 23andMe to "immediately discontinue marketing" its genetic testing kits, saying that the company has repeatedly failed to prove the product actually works. The Google-backed company offers mail-in genetic testing, which it promises can reveal your risk for various health conditions and drug allergies. In a sharply-worded warning letter addressed to co-founder and CEO Anne Wojcicki, the FDA says it fears false positives could cause consumers to undergo unnecessary procedures, while false negatives could make them miss actual warning signs. The FDA says it's had "more than 14 face-to-face teleconference meetings" and "hundreds of email exchanges," with the company, and provided "ample detailed feedback" on what it must do. But "we still do not have any assurance that the firm has analytically or clinically validated the [test] for its intended uses." The company has 15 days to respond, and has released a statement saying it realizes it hasn't "met the FDA's expectations regarding timeline and communication." The case is being carefully watched as a sign for how the FDA will deal with genetic testing, experts tell the Washington Post.