The Food and Drug Administration (FDA) has been targeting inaccurate medical tests that have provoked unnecessary abortions, surgeries, prescriptions and an increase in medical costs. In the growing industry of laboratory-developed tests, the federal administration has been searching for ways to regulate and create stricter standards.
Some recent laboratory-developed tests haven’t been proven to be effective or reliable and yet being used. Without regulations, these tests are being used on patients that are then misinformed about their condition. The misinformation is the cause of several unnecessary procedures and increased medical costs for patients who are healthy or whose conditions are not fatal.
“Doctors and patients rely on these tests to make well-informed healthcare decisions. If they get inaccurate results, they can make the wrong decisions, and people get hurt as a result,” says Dr. Jeffrey E. Shuren, director of the Center for Devices and Radiological Health at…
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