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New Federal Taskforce to Speed Implementation of Emergency Use Diagnostics

Three federal agencies announced the creation of a new taskforce to provide timely recommendations to laboratories for rapid implementation of in vitro diagnostic (IVD) assays during public health emergencies.

The 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. The taskforce’s charter calls for coordination of the implementation of IVD assays authorized for use under FDA’s Emergency Use Authorization (EUA) in laboratories within the U.S. healthcare system—both public health and clinical laboratories—with the ultimate goal of improving responses to public health emergencies.

“Time and time again, we’re reminded that disease knows no borders,” said Chesley Richards, CDC’s Deputy Director for Public Health Science and Surveillance, in a statement. “During public health emergencies, it is critical for diagnostic tests to be made available and adopted quickly into clinical and public health laboratories for rapid patient care.”

The taskforce will provide a forum to streamline interagency approaches for the implementation of EUA diagnostic tests through better federal communication and leveraging of each agency’s expertise to assist in public health preparedness and improve the availability of these diagnostic tests in times of emergencies.

The FDA has authority to issue an EUA for appropriately developed diagnostic tests during public health emergencies. 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 often also develop new tests in response to emergency needs. CMS has authority to ensure quality testing at laboratories through the Clinical Laboratory Improvement Amendments (CLIA).

“Timely implementation of EUA diagnostic assays in the U.S. health care system is dependent upon laboratories understanding the instructions for use and applying them to the patient samples received for testing,” said CMS’ chief medical officer and director of the Center for Clinical Standards and Quality Kate Goodrich, in a statement. “As part of this taskforce, it is our goal to provide clear and consistent guidance to laboratories on the application of CLIA requirements for these emergency assays.”

According to public feedback received by the agencies, the clinical laboratory community had concerns about how to implement EUA diagnostic tests in a CLIA environment.

Takeaway: Ultimately, the taskforce is expected to provide a more efficient federal government response to speed implementation of available diagnostic tests during public health emergencies.

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