Without question, medical testing has saved lives and bettered patient care. But what happens when tests are inaccurate or unnecessary? The U.S. Food and Drug Administration (FDA) recently raised alarms about a growing class of tests designed and used in single laboratories, which are far less subject to regulatory enforcement than commercial test kits sold to multiple labs. The agency reviewed 20 case studies involving lab-developed tests (LDTs) and found evidence of patients at risk for medically unnecessary procedures, including mastectomies, or for potentially inappropriate therapies, including cancer treatments. Some tests may fail to detect a condition, while others may erroneously point to a non-existent problem. The medical costs are significant. The Obama administration is calling for a new regulatory framework as well.

LDTs are not the only source of concern. A 2013 meta-analysis involving commonly ordered lab tests found that 30 percent, on average, were probably unnecessary and, conversely, a similar number should have been ordered and were not.

Scrutiny of lab testing is intensifying as the medical community grapples to address diagnostic errors. This year, the Institute of Medicine issued a study, Improving Diagnosis in Health Care, as a continuation of an earlier series of patient safety reports. Pointing to many factors in diagnostic errors, the recent report states that “most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.”

Presented December 11, 2015 in collaboration with STAT, This Forum examined the role of medical tests in health care, looking both at their considerable benefits and risks and asking how to ensure their accuracy, safety and reliability.

Watch the entire series from The Forum at Harvard T.H. Chan School of Public Health at www.ForumHSPH.org.

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