Payers and technology assessments currently evaluate diagnostic tests in terms of three categories of information. These are “analytical validity” (the performance features of the test), “clinical validity” (the correlation between the test result and clinical conditions), and “clinical utility” (the impact of test deployment on healthcare outcomes.)

Unfortunately, this framework has proved too general to facilitate clear communications between innovators and payers, and may often result in unhelpful conclusions (“the test doesn’t have enough clinical utility, and needs more clinical utility.”)