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. “The challenge is… if the FDA is going to follow that same approach to [review] 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. The FDA’s decision is expected in late June or early July.