Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools.
Many Americans might have assumed that the FDA already had oversight of all medical tests; it does not.
But thousands of so-called "laboratory developed tests" , analyzed at many high-tech labs, face no FDA oversight. These tests are often highly sophisticated and are used to identifyThe science around these tests has evolved significantly since many first came into use decades ago. "The agency has become increasingly concerned that some LDTs may not provide accurate test results or perform as well as FDA-authorized tests," the agency said."The FDA is concerned patients could initiate unnecessary treatment, or delay or forgo proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death," the agency warned.
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