In another about-face, the FDA announced this past Friday that it would regulate LDTs. Those of us with some history in the field of diagnostics are saying, “Here we go again.” The last round during the Obama administration (towards the end, I might add—why not at the beginning?) had all of the interested parties putting on their best arguments for and against or somewhere in between. As soon as we had all weighed in with our brilliance, Trump was elected.