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Report: Inaccurate Testing Drives Up Health Care Costs

Authors call for increased FDA oversight

Unreliable, inaccurate medical testing is a major obstacle to patient safety, hiking unnecessary medical and drug expenses as well as prompting unneeded medical procedures, according to a new report from the FDA’s Office of Public Health Strategy and Analysis.

Laboratory-developed tests (LDTs) serve an increasingly important role in health care. They also have become significantly more complex and higher risk, with several notable examples of inaccurate tests placing patients at otherwise avoidable risk, the authors note.

While laboratories that offer LDTs are subject to the Federal Food, Drug, and Cosmetic Act, in addition to the Clinical Laboratory Improvement Amendments (CLIA), the FDA has generally exercised “enforcement discretion” towards these tests, according to the report. Therefore, most laboratories that offer LDTs follow only the regulatory requirements of the CLIA, which are intended to regulate the operations of laboratories but are not specifically intended to regulate in vitro diagnostic devices. Despite the contention from some that “the CLIA is enough,” all of the tests described as problematic in the new report were offered from laboratories following the minimum requirements of the CLIA.

“We examined events involving 20 LDTs that illustrate, in the absence of compliance with FDA requirements, that these products may have caused or have caused actual harm to patients,” the authors write. “In some cases, due to false-positive tests, patients were told they have conditions they do not really have, causing unnecessary distress and resulting in unneeded treatment. In other cases, the LDTs were prone to false-negative results, in which patients’ life-threatening diseases went undetected. As a result, patients failed to receive effective treatments.”

Other LDTs provided information with no proven relevance to the disease or condition for which they were intended for use, while others were linked to treatments based on disproven scientific concepts.

The authors concluded that their findings “highlight the need for greater FDA oversight of LDTs that is appropriately tailored so that it is complementary and does not duplicate the oversight currently provided under the CLIA.”

Source: FDA, November 16, 2015

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