Administration Declines to Issue FDA Guidance on LDT Oversight
WASHINGTON, D.C. – November 18, 2016 – The U.S. Food & Drug Administration (FDA) announced today that it will not release final guidance on oversight of laboratory developed tests (LDTs) that are used for making critical diagnostic and treatment decisions made by patients and their health care providers.
A statement from the American Cancer Society Cancer Action Network (ACS CAN), follows:
“We’re disappointed the FDA is not exerting its authority to actively oversee LDTs. Without such regulation, patients and their providers may not be able to have confidence in the quality and veracity of test results to make critical decisions. The FDA had undertaken an extensive process of soliciting public input over the past several years to create a policy that balances innovation with safety. It is regrettable that important patient and clinician feedback will not be realized.
“Current oversight of LDTs falls short of ensuring these tests produce accurate and meaningful results. Until now, many tests have come to market without independent verification that their results were accurate or clinically valid. Without final guidance, labs that want to perform tests to diagnose diseases where the test is critical to safety, health or a treatment decision will not be required to validate a test’s accuracy and clinical claims with FDA. Further, they will not have to report adverse events impacting patient health.
“The FDA is the most appropriate agency to evaluate the analytical and clinical validity of diagnostic tests, along with their safety, to help ensure that cancer patients and their doctors are able to make appropriate treatment decisions based on accurate information. In an era of precision cancer medicine, diagnostic tests are the foundation of personalized care and oversight is imperative to ensure the foundation can be trusted.
“ACS CAN calls on the new administration to prioritize the safety of patients and continue work with stakeholders to develop and implement a framework for LDT oversight.”