Unregulated Medical Tests May Be Putting Patients at Risk of Harm, Unnecessary Treatment

December 11, 2015 | Strategic Insights for Ambulatory Care


​Patients have been harmed or have undergone unnecessary treatments as a result of unreliable medical tests that do not meet U.S. Food and Drug Administration (FDA) requirements, the agency states in a report to Congress that was also summarized in a November 23, 2015, New York Timesarticle. In its report, FDA concluded that the lack of oversight of laboratory-developed tests has resulted in patients undergoing unnecessary surgeries, taking drugs they do not need, and in some cases, considering abortions based on the results of unreliable genetic tests.

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