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Lab-developed tests (LDTs) may be producing erroneous results

The FDA said certain lab-developed tests (LDTs) may be producing erroneous results. LDTs are produced and performed in a single hospital and do not utilize standard diagnostic equipment. LDTs can involve prenatal tests, ovarian cancer, whooping cough and human papillomavirus. William Riley, of Riley Williams & Piatt, LLC, stated, “It is important for the FDA to step in and regulate these tests under existing medical device law. Some laboratories are marketing this service on a national basis and these test results are too important to patients to leave in an unregulated Wild West environment.” For more information please visit: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407296.htm