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Are laboratory-developed medical tests safe?

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If your doctor in New York City recommends a medical test during a routine checkup or as a result of symptoms, it should be safe to assume that the results will be accurate. However, according to the New York Times, the U.S. Food and Drug Administration believes that a lack of oversight has led to a number of faulty medical tests. These tests are developed by and for individual laboratories and are not distributed to others, so they do not undergo the review process.

Industry leaders disagree with the FDA, citing the potential to stunt innovation as a reason to prevent the tests from being regulated by federal guidelines. However, a review of 20 case studies by the agency indicates that there is significant harm or threat of harm to patients who undergo laboratory-developed medical tests that have not been appropriately vetted for safety or reliability.

In addition to better regulation of this type of test, the FDA report to Congress urges a better reporting system. As a consumer, you can report adverse events for many types of medical procedures through the FDA, but laboratory-developed tests are not included in that system. Because there are not consistent records, the agency claims there is no way to know how many people have been harmed already.

Based on the case studies, the FDA estimates that patient harm or the potential for harm from these tests has included healthy ovaries being removed, healthy babies being aborted, improper medication or wrong dosages administered and other serious medical errors. This information about unregulated medical testing should not be considered legal advice and is provided only for educational purposes.


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