The US Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) have partnered to launch a task force to boost availability of diagnostics during public health emergencies.
The Tri-Agency Task Force for Emergency Diagnostics will leverage each agency’s expertise to drive the development and deployment of diagnostic tests in clinical and public health laboratories.
FDA Center for Devices and Radiological Health director Jeffrey Shuren said: “This task force will help our agencies better collaborate to prepare for and respond to, public health threats, including identifying threats and ensuring the appropriate diagnostics are in place to support efforts in the field.”
FDA, CDC as well as CMS respond during public health emergencies through identification of threats, regulation of medical products and offer oversight for laboratories, among others.
Certain diagnostics, such as tests for Ebola and Zika, could be made available through the Emergency Use Authorization (EUA) process during a crisis.
The FDA holds the authority to issue an EUA, while the CDC provides agent-specific subject matter expertise and guidance. CDC and other federal laboratories often create new tests to respond to emergencies.
CMS has the authority to ensure quality testing through the Clinical Laboratory Improvement Amendments (CLIA ). It offers guidance required by laboratories to deliver accurate, reliable and timely results.
Through this emergency diagnostics task force, these agencies intend to help clinical laboratories implement the EUA-authorised diagnostic tests during emergencies.
The partners also aim to address unmet needs and gaps in preparing and responding to global health threats.
A forum will be made available by the Tri-Agency Task Force for each agency to coordinate, offer consultation and enhance the availability of diagnostic tests during public health emergencies.
The task force will also define, refine and optimise interagency methods to implement EUA tests. Ultimately, the initiative is expected to provide a more efficient federal government response to make the diagnostic tests available.