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The FDA issued a 39-page report in November, titled “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies,” which addresses bad outcomes that result from certain laboratory-developed tests (LDTs), which are increasingly important, considering their use can lead to a patient’s diagnosis and surgery.
Most laboratories that offer LDTs follow the Clinical Laboratory Improvement Amendments (CLIA) as well as the Food, Drug, and Cosmetic (FD&C) Act. However, the FDA generally has not used the FD&C Act to exercise enforcement.
Most laboratories that offer LDTs follow only the regulatory requirements of CLIA, which are intended to regulate the operations of laboratories, but are not specifically intended to regulate in vitro diagnostic devices. Some argue CLIA is sufficient enough, but the 20 tests the FDA identified as problematic were all laboratories that were in compliance with the CLIA regulations.
The FDA says the 20 LDTs it examined show, in the absence of compliance with FDA requirements, such products may have caused or have caused harm. False-positive tests led patients to believe they had non-existent conditions, resulting in unnecessary stress and unneeded treatment. Conversely, other LDTs were prone to false-negative results, in which patients did not receive proper diagnoses nor proper treatments to combat life-threatening diseases.
In the future, physicians can expect more FDA oversight for lab tests that are designed to examine tissue samples. This will further efforts to prevent using tests that can lead to adverse outcomes in patients, including misdiagnosis and unnecessary treatment. This may be crucial to ensuring patient safety.
The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies, is available at: www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm472773.htm.
The full report is available at: www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM472777.pdf.