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AACR's Policy Statement Urges FDA-Regulation of Laboratory-Developed Tests
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
Source: AACR
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Texas Oncology to Roll Out Canopy for ePROs After Head-to-Head Pilot
March 18th 2025Debra Patt, MD, PhD, MBA, executive vice president of Public Policy and Strategy for Texas Oncology, said the practice received positive feedback from nurses and patients during a pilot that concluded in February.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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