Patients, Doctors and Researchers Commend the FDA for Proposal to Modernize Oversight of Laboratory Developed Tests

WASHINGTON, D.C. – December 10, 2014  – The American Cancer Society Cancer Action Network (ACS CAN) together with a dozen groups representing patients, doctors and researchers submitted a letter to the Food and Drug Administration today commending the agency for a proposal that aims to implement appropriate and efficient oversight of laboratory developed tests (LDTs).

The groups support consistent evaluation of tests and tools that have the power to inform diagnosis and treatment decisions.  Currently tests sold as complete kits are required to undergo pre-market clearance and approval from the FDA to verify safety and effectiveness of the test. Similar tests that laboratories create for their own use are not subject to the same level of safety review and performance validation.

Referring to LDTs, the groups wrote, “There is a growing reliance on these tests by doctors and patients to make diagnosis and treatment decisions. This growing reliance, however, means that the risks to patients are much higher if these tests do not perform as expected. False results, or missed or incorrect diagnoses, could mean that patients either will not receive the therapy they need, or will be subject to the adverse effects and costs of therapy that will not work for them.”

The groups support a risk-based approach to regulation of LDTs that would support both innovation and public health.

ACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. ACS CAN works to encourage elected officials and candidates to make cancer a top national priority. ACS CAN gives ordinary people extraordinary power to fight cancer with the training and tools they need to make their voices heard. For more information, visit www.fightcancer.org.

FOR MORE INFORMATION, CONTACT:
Alissa Crispino or Steven Weiss
American Cancer Society Cancer Action Network
Phone: (202) 661-5772 or (202) 661-5711
Email: [email protected] or [email protected]

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