Inside STAT: FDA warns test companies not to tell patients about gene-drug links 

(ALEX HOGAN/STAT)

As tests to gauge how genetics affect the way people respond to medications go mainstream, the FDA is beginning to exercise more caution. It’s concerned that patients could start or stop taking medications based on insufficient evidence from such drug-gene links, known as pharmacogenetics. The agency has gone so far as to quietly tell several companies offering tests based on these links to stop reporting results about specific medications. Myriad Genetics, Color, and Genomind all offer physician-ordered pharmacogenetics tests, but confirmed that they recently made or proposed changes in response to pushback from the FDA. Even the major nationwide study “All of Us,” which champions sharing results back with patients, is weighing how best to share information about gene-drug interactions with study participants. STAT Plus subscribers can read more here from STAT’s Rebecca Robbins.