ACS CAN Applauds FDA’s Rule on Laboratory Developed Test Regulation

New rule welcome while Congress works to pass legislation to modernize diagnostics oversight

April 29, 2024

WASHINGTON, D.C. – Today, the Food and Drug Administration (FDA) finalized a new rule regulating laboratory developed tests (LDTs) that will harmonize oversight for diagnostic tests regardless of whether tests are performed in individual laboratories or sold as prepackaged kits. For the past several years, the American Cancer Society Cancer Action Network (ACS CAN) has joined with a broad coalition of stakeholders in calling for legislative reform of the diagnostics space, specifically supporting the Verifying Accurate, Leading-edge IVCT Development (VALID) Act as way to achieve that reform. This legislation would modernize and harmonize diagnostics oversight. Until Congress can act, the FDA’s rule will be a positive step toward ensuring uniform review of all tests intended for the same purpose. 

Currently, diagnostic tests undergo widely different oversight depending on whether they are submitted to the FDA for review or are offered as LDTs, which does not involve any premarket review. This difference opens the door to the possibility that test results for the same sample may vary depending on where the test is conducted, potentially leading to incorrect treatment decisions and patient harm if a test result is not valid.  

“Cancer patients rely on accurate and clinically valid diagnostic tests to optimize their treatment options,” said Lisa A. Lacasse, president of ACS CAN. “The overarching goal for diagnostic reform is to ensure that patients have confidence in the results of diagnostic tests, which have become increasingly critical in the management of cancer. Cancer patients and their physicians should be able to trust the information produced by a diagnostic test regardless of where that test is conducted. As the regulations are implemented, we call on Congress to provide FDA with any necessary resources for the increased workload and to pass comprehensive legislation, such as the VALID Act, as soon as possible.”