Calling the current regulatory system for laboratory developed tests (LDTs) “inadequate and in urgent need of updating,” the American Cancer Society Cancer Action Network and 32 other organizations sent a letter to U.S. Senate leaders urging them to update the oversight framework for all molecular diagnostic tests, with an emphasis on LDTs.
“It is imperative that patients and physicians are assured of the accuracy and reliability of these test results when making vital health decisions,” write the letter’s signees. “Currently, diagnostic tests undergo widely different levels of oversight depending on whether they are submitted to the U.S. Food and Drug Administration for review or are offered as LDTs.”
Citing the increased complexity of current LDTs and the fact these tests are increasingly performed in reference laboratories with national reach, the organizations, representing patients, scientists, advocates, caregivers, and health care professionals, say that CLIA regulation does not adequately address the “safety and effectiveness” of LDTs.
Under CLIA, laboratories are required to demonstrate the analytical validity of the tests they offer (the test’s reproducibility), but CLIA does not ensure consistent performance for measuring the same analyte across laboratories, the Cancer Action Network says. Additionally, the organizations stress that CLIA does not evaluate the clinical validity of a test—the test’s ability to accurately diagnose a condition.
“There is no systemic way to be sure of the accuracy and reliability of these tests,” say the signees. “The current oversight framework creates inconsistencies in oversight and can leave FDA with limited options to catch and address problematic LDTs.”
As further evidence of the need for updates to the oversight framework, the organizations cite a Dec. 15, 2016 study in JAMA Oncology that reported “markedly” different test results from two different commercially available, next-generation sequencing-based tumor profiling tests (See the March issue of DTET for more details).