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FDA Expanding Oversight of Certain Diagnostic Tests

The U.S. Food and Drug Administration (FDA) recently announced that it is taking steps to increase its oversight over certain diagnostic tests used to help diagnose and treat patients.

Under the agency’s current regulatory framework, many laboratory developed tests (LDTs), which are designed, manufactured and intended to be used in a single laboratory, do not undergo premarket review. Accordingly, their accuracy and reliability may not be supported by clinical tests.

As highlighted in an FDA blog post, the agency has traditionally exercised enforcement discretion over LDTs. However, these tests have recently grown more complex and high risk. Moreover, while they were previously only used in conjunction with rare illnesses, they are now being used to detect the risk for breast cancer and Alzheimer’s disease. LDTs also frequently compete with tests that are approved by the FDA.

Accordingly, the FDA is proposing to establish an LDT oversight framework, which would include pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market. Under its proposed guidance, enforcement of pre-market review for other high risk and moderate risk LDTs would be phased in over time.

“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, M.D. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”