FDA Regulation of Laboratory Developed Tests Will Improve Patient Safety

Updated August 4, 2014

WASHINGTON, D.C. -- July 31, 2014 -- The Food and Drug Administration (FDA) today announced its intention to release a draft framework to regulate laboratory developed tests (LDTs) that are used for making critical diagnostic and treatment decisions made by patients and their health care providers. The framework states that the FDA intends to regulate copies of FDA-approved tests, copies of Class III medical devices, and tests associated with blood safety. The FDA does not plan to regulate tests for rare diseases or tests where there is no other approved test.

A statement from ACS CAN President Christopher W. Hansen follows:

Genetic tests have greatly improved cancer outcomes thanks to the accuracy of diagnoses and precision of treatment regimens in recent years. While early LDTs were relatively simple, low-risk tests, technological advances have created the need for more complete regulation of such tests that provide information that can lead to a specific course of treatment.

With diagnostic testing and targeted therapies on the rise, the stakes are now higher for cancer patients. LDTs are becoming more numerous, more complex, and have the potential to have a bigger impact on health care decisions.

Until now, many tests have come to market without independent verification that their results were valid or accurate. This important change will require labs who want to perform lab tests to diagnose diseases where the test is critical to safety, health or a treatment decision to submit information like reports of adverse events to the FDA for review.

As patients and doctors become more reliant on diagnostic tests to provide this information, it is critical that they are valid and accurate. Cancer patients and survivors commend the FDA for taking this critical step to ensure that patients have access to safe and effective diagnostic tests that can be trusted.

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 https://www.fightcancer.org/.

For More Info, Contact:

Alissa Crispino or Steven Weiss

Phone: 202-661-5772 or 202-661-5711

Email: [email protected] or [email protected]

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