U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.
The FDA, CDC and CMS each play a critical role in responding to public health emergencies, including identifying threats, regulating medical products, and providing oversight for laboratories. The agencies have robust teams of scientists, researchers and policy experts that are dedicated to preparing the U.S. for rapid disaster response.
Diagnostic tests—such as those that can detect pathogens like the Ebola and Zika viruses—can be quickly made available to meet response needs during a crisis through the Emergency Use Authorization (EUA) process. The FDA has authority to issue an EUA for the use of diagnostic tests during public health emergencies, provided criteria are met. The CDC is responsible for providing agent-specific subject matter expertise in epidemiology, laboratory expertise and guidance to clinicians and laboratories responding to the emergency. The CDC and other federal laboratories are often the ones developing new tests to respond to emergency needs. CMS has authority to ensure quality testing at laboratories through the Clinical Laboratory Improvement Amendments (CLIA). CMS provides guidance, even during public health emergencies, to laboratories on meeting CLIA requirements to ensure laboratories produce accurate, reliable and timely results.
Prior to this partnership, feedback from the clinical laboratory community indicated that there was uncertainty about how to implement the diagnostic tests once they received an EUA; particularly, the community was uncertain about meeting CLIA regulations under an EUA to allow labs to start testing specimens.
By standardizing collaboration efforts, the federal partners hope to address issues related to implementation of diagnostic tests authorized for emergency use under an EUA, as well as other unmet needs and gaps in preparing and responding to global health threats. The task force will provide a forum for each agency to coordinate, provide consultation, and improve the availability of diagnostic tests during public health emergencies. In addition, to assist in public health preparedness, the task force will work to define, refine and streamline interagency approaches for the implementation of EUA diagnostic tests. The hope is that the task force will enable an even more efficient federal government response for making diagnostic tests available in the event of a public health emergency.
