41-42 Advocacy Organizations Urge Congress to Consider FDA’s Expertise in Regulating Lab-Developed Tests

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Advocacy Organizations Urge Congress to Consider FDA’s Expertise in Regulating Lab-Developed Tests

A group of 42 organizations sent an open letter to a congressional committee urging them to consider the important role of the FDA in the regulation of laboratory-developed tests.

Ahead of next week’s hearing of the House Energy and Commerce Committee, titled “Examining the Regulation of Diagnostic Tests and Laboratory Operations,” the letter addressed concerns that agency involvement would impede patient access to LDTs, saying that the FDA has a track record of approving new technologies in a timely manner.

“In 2013 FDA allowed marketing of four next-generation sequencing (NGS) diagnostic devices, the first-ever clearance of its kind,” the authors wrote.

“The FDA developed the expertise and tools to conduct a thorough review and used separate approval pathways to reflect the risk associated with each device. The FDA’s draft guidance on LDT oversight also reflects a commitment to flexibility, given the proposal’s risk-based approach to oversight.”

The organizations, which include Friends of Cancer Research, the American Association for Cancer Research, the American Cancer Society Cancer Action Network, and the American Society for Clinical Oncology, noted examples when FDA oversight was necessary to protect patients.

“The discovery of faulty and clinically invalid tests being used in ovarian cancer (OvaSure) and cardiology (KIF6 testing) highlights examples of inadequate oversight,” the authors wrote. “Apart from these examples, the general lack of publicly-available information about many LDTs has raised concerns among many that not enough is known about many tests currently in use.”

“The FDA can provide the assurance that when tests are performed they lead to the proper use of associated treatments, a step that’s necessary to improve the public health.”

The full letter can be read here.

The full list of signed organizations includes: Action to Cure Kidney Cancer; Addario Lung Cancer Foundation; Addario Lung Cancer Medical Institute; The ALS Association; Alliance for Aging Research; American Association for Cancer Research; American Autoimmune Related Diseases Association; American Brain Tumor Association; American Cancer Society Cancer Action Network; American Heart Association; American Medical Student Association; American Society of Clinical Oncology; Annie Appleseed Project; Breast Cancer Action; CancerCare; Cancer Prevention and Treatment Fund; Cancer Support Community; C-Change; Connecticut Center for Patient Safety; Cutaneous Lymphoma Foundation; Fight Colorectal Cancer; Friends of Cancer Research; Kidney Cancer Association; Kids v. Cancer; The Leukemia & Lymphoma Society; Lung Cancer Alliance; LUNGevity; Lupus and Allied Diseases Association Inc.; Melanoma Research Alliance; MRSA Survivors Network; National Brain Tumor Society; National Coalition for Cancer Survivorship; National Consumers League; National Multiple Sclerosis Society; National Organization for Women; National Patient Advocate Foundation; National Physicians Alliance; Ovarian Cancer National Alliance; Prevent Cancer Foundation; US Pain Foundation; WomenHeart: The National Coalition for Women with Heart Disease; and Woody Matters.