Companies that offer direct-to-consumer genetic tests must seek approval from the US Food and Drug Administration (FDA), while similar tests that are ordered by doctors are given the FDA green light. Yet physician-approved tests have led some to question the level of the medic’s involvement, given that the companies can choose the doctor and solicit the order after a consumer has purchased the test online. The FDA’s decision is expected in late June or early July.
Companies that offer direct-to-consumer genetic tests must seek approval from the US Food and Drug Administration (FDA), while similar tests that are ordered by doctors are given the FDA green light. Yet physician-approved tests have led some to question the level of the medic’s involvement, given that the companies can choose the doctor and solicit the order after a consumer has purchased the test online. With a seemingly fine line between the two types of offering and genetic-testing technology surging ahead, companies are urging the regulatory framework to catch up.