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33 Health Organizations Urge Congress to Update Oversight Rules for Laboratory Developed Tests
January 25, 2017
WASHINGTON, D.C. – January 25, 2017 – Yesterday, the American Cancer Society Cancer Action Network (ACS CAN) and 32 other organizations sent a letter to Congressional leadership urging them to update oversight rules for all diagnostic tests, including laboratory developed tests (LDTs). The groups, which represent patients, scientists, advocates, caregivers, and health care professionals, also want the U.S. Food and Drug Administration (FDA) to play a central role in future oversight of such tests.
LDTs are tests created and performed within a single laboratory and are increasingly used to predict, diagnose and treat serious diseases like cancer; however, LDTs are not required to prove their accuracy, reliability or report any adverse effects.
As patients and their doctors become more reliant on diagnostic tests during the treatment decision process, it is critical that the tests produce accurate, meaningful, and consistent results.
“While we recognize that molecular diagnostics are complex and that changing the oversight paradigm will be difficult, we also know that ensuring good science will lay a strong foundation for innovation. We also believe strongly that FDA should play a critical role in any new framework. We stand ready to work with you on this important patient safety issue,” the letter states.
Read the full text of the letter for more information.
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FOR MORE INFORMATION, CONTACT:
Jill Courtney or Alissa Crispino
American Cancer Society Cancer Action Network
Phone: (202) 585-3278 or (202) 661-5772
Email: [email protected] or [email protected]
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