AACR issues policy statement to urge FDA to provide oversight of high risk laboratory developed tests

Sept. 12, 2014

The American Association for Cancer Research (AACR) recently issued a policy statement that recommends that the U.S. Food and Drug Administration (FDA) begin to actively exert its authority to regulate high-risk laboratory developed tests (LDTs) that are being utilized by physicians to make treatment decisions, including the tailoring of an individual's cancer treatment regimen.

“FDA's policy of enforcement discretion over LDTs was acceptable when these tests were mostly routine laboratory procedures; however, as LDTs have evolved in complexity, the risk posed to patients has also increased,” says Charles L. Sawyers, MD, immediate past president of the AACR and chair of the Human Oncology and Pathogenesis Program at the Memorial Sloan Kettering Cancer Center in New York, and co-author of the policy statement. “It is therefore vital that all diagnostic tests used to make high-risk treatment decisions be FDA-approved, so patients and physicians can be assured of the test's safety and accuracy,” he added.

The AACR believes that an evidence-based regulatory framework will ensure that future treatments and cures will reach patients in an efficient and expeditious manner. Implementation of a risk-based framework by the FDA that would provide for evaluation of all high-risk molecular diagnostic tests would balance the need for encouraging innovative medical product development with the need for ensuring patient safety.

“Diagnostic tests play a central role in the success of personalized medicine by helping oncologists identify the right treatment for the right patient,” says Margaret Foti, PhD, MD, chief executive officer of the AACR. “Therefore, we strongly support the FDA exerting its authority to regulate LDTs that pose a high risk to cancer patients.” Read more about advocacy and policy opinions of the AACR.

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