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Unreliable Lab Tests Harming Patients, FDA Warns

November 23, 2015 — Inaccurate and unreliable laboratory tests harm patients when they are treated for diseases they do not have or die from diseases that were misdiagnosed, according to a report (PDF) by the FDA.

The FDA is asking Congress for expanded authority to regulate so-called “laboratory developed tests” (LDTs), which are diagnostic tests that are developed and used by a single laboratory. In the past, LDTs were simple tests used for rare diseases.

In recent years, the industry has boomed with tests for increasingly complex and common diseases like cancer, heart disease, and prenatal genetic conditions. For these patients, the impact of a false-positive or false-negative can be devastating.

According to the FDA:

“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 disease went undetected.”

The FDA analyzed adverse events associated with 20 different LDTs. For example, one test failed to detect the HER2 gene mutation associated with aggressive breast cancer 20% of the time. That means patients did not receive the best medications that target HER2.

Pregnant women also had abortions because the tests inaccurately indicated abnormalities in the fetus. The problem has led to unnecessary surgeries and tens of thousands of people on unneeded drugs, according to the New York Times.

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