The statement points to the increased complexity of some of the LDTs and highlights patient safety issues that are at stake.
The American Association for Cancer Research (AACR) issued a policy statement Tuesday, Sept. 9, that underscores the importance of safe, accurate, and effective diagnostic tests by recommending 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," said Charles L. Sawyers, MD, immediate past president of the AACR, 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 said.
Read the complete statement: http://bit.ly/1qdMKHm