Supporting FDA Regulation of LDT's

Cancer patients rely on accurate and clinically valid diagnostic tests, which have become increasingly critical in the management of cancer. Prior to a rule issued by the Food and Drug Administration (FDA) in May of 2024, diagnostic tests underwent widely different oversight depending on whether they were submitted to the FDA for review or were offered as laboratory developed tests (LDTs), which did not involve any premarket review, product registration listing, or adverse event reporting. The difference opened the door to the possibility that test results for the same sample could vary depending on where the test was conducted, potentially leading to incorrect treatment decisions and patient harm if a test result is not valid.

In the case of American Clinical Laboratory Association et al v. FDA, plaintiff laboratories challenged the rule, claiming FDA lacks the authority to regulate LDTs.  ACS CAN and five other organizations representing patients and providers filed an amicus curiae, or “friend-of-the-court,” brief  . The amicus brief supports the FDA’s rule regulating LDTs that harmonized oversight for diagnostic tests regardless of whether tests are performed in individual laboratories or sold as prepackaged kits to ensure the safety and effectiveness of LDTs as they play an increasingly critical role in the diagnosis and treatment of disease.  Read our statement.