Since last October, the FDA has been signaling to patients and healthcare providers to exercise caution when applying the results of direct-to-consumer (DTC) pharmacogenomics testing to prescribing drugs. That signal got stronger in April when the FDA sent a warning letter to the genomics testing lab Inova, instructing it to modify labeling and marketing materials for several pharmacogenomics tests. Now some genomics companies, among them Color, Genomind and OneOme, as well as the NIH-sponsored All of Us Program, report that they are in discussions with the FDA and in some cases have already modified their informational materials. The tests at issue are mostly lab-developed tests, which typically are exempt from regulatory review so long as the testing lab is CLIA certified. However, FDA has the right to revoke that exemption in cases where public safety is at issue. With DTC marketing of pharmacogenomics tests, the fear is that individuals will modify their drug use on their own. Whereas companies profess that the FDA is not clear on which tests it considers dubious, the agency appears to be drawing the line at tests not described in drug labels. So far, 23andme is the only DTC genomics testing company that has an approved pharmacogenomics test: its Personal Genome Service Pharmacogenetic Report tests for multiple variants in eight genes that affect the metabolism of some 50 drugs. Further confusing the issue, United HealthCare in August announced that it will cover panels of genetic test for guiding the use of drugs for major depression and other depressive disorders, although the American Psychiatric Association’s research council last year concluded that the evidence for testing in those indications is not conclusive.