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

On Behalf of | Jan 11, 2023 | Blog

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 Law Group, 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