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

WASHINGTON, D.C. – Today, six organizations representing millions of patients and providers, filed an amicus curiae, or “friend-of-the-court,” brief in the case of American Clinical Laboratory Association et al v. U.S. Food and Drug Administration (FDA) in the U.S. District Court in the Eastern District of Texas. The amicus brief supports the FDA’s laboratory developed tests (LDTs) rule that harmonized oversight for diagnostic tests regardless of whether tests are performed in individual laboratories or sold as prepackaged kits.

Prior to the rule, diagnostic tests underwent widely different oversight depending on whether they were submitted to the FDA for review or were offered as 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.

Cancer 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. Cancer patients and their physicians should be able to trust the information produced by a diagnostic test regardless of where that test is conducted.

Below is an excerpt from the brief:

“Amici support the decision of the Food and Drug Administration (FDA) to regulate laboratory developed tests as medical devices under the Food, Drug, and Cosmetic Act (FDCA). Amici believe that FDA regulation is necessary to ensure the safety and effectiveness of laboratory developed tests and are concerned that 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…

“The record confirms that laboratory developed tests today play an increasingly critical role in the diagnosis and treatment of disease and that FDA regulation is needed to ensure that devices manufactured by laboratories are safe and effective, just as devices manufactured by other types of entities must be.”

List of organizations:

American Cancer Society Cancer Action Network

American Society of Clinical Oncology

Friends of Cancer Research

National Brain Tumor Society

Ovarian Cancer Research Alliance

Public Citizen

The organizations are represented by Public Citizen on a pro bono basis.