Patient, Research, and Provider Groups File Amicus Brief Supporting FDA’s Rule on Laboratory Developed Tests

November 4, 2024

Patient, Research, and Provider Groups File Amicus Brief Supporting FDA's Rule on Laboratory Developed Tests

WASHINGTON, D.C. - Today, Public Citizen, on behalf of itself and five other organizations representing millions of patients and providers, filed an amicus curiae brief in the case of American Clinical Laboratory Ass'n et al v. U.S. Food and Drug Administration, a case pending in the U.S. District Court in the Eastern District of Texas. The amicus brief supports the FDA's laboratory developed tests rule, which harmonizes oversight for diagnostic tests developed in laboratories with other diagnostic tests, such as those sold as prepackaged kits.

Before issuing the rule, the FDA treated laboratory developed diagnostic tests differently than other diagnostic tests by not requiring them to undergo premarket review, product registration listing, or adverse event reporting. Because of the difference in treatment, test results for the same sample could vary depending on where the test was conducted, potentially leading to incorrect treatment decisions and patient harm.

Patients rely on accurate and clinically valid diagnostic tests to optimize their treatment options. 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. Patients and their physicians should be able to trust the information produced by a diagnostic test, regardless of where that test is conducted.

The amicus brief explains that FDA regulation is necessary to ensure the safety and effectiveness of laboratory developed tests and are concerned that the plaintiffs' challenge, if successful, would result in substantial harm to patients who rely on such tests to diagnose and treat cancer and other medical conditions. And because laboratory developed tests play an increasingly critical role in the diagnosis and treatment of disease, FDA regulation is needed to ensure that devices manufactured by laboratories are safe and effective, just as devices manufactured by other entities must be.

Along with Public Citizen, the organizations that joined the brief are American Cancer Society Cancer Action Network, American Society of Clinical Oncology, Friends of Cancer Research, National Brain Tumor Society, Ovarian Cancer Research Alliance.

The brief is available here.