Feds team up to speed diagnostic testing access in emergencies
- The Centers for Disease Control and Prevention, FDA and CMS announced Tuesday the launch of a task force aimed at ensuring the public has access to diagnostic tests during a public health emergency such as an Ebola or Zika outbreak.
- The Tri-Agency Task Force for Emergency Diagnostics (TTFED) aims to disseminate information to labs during an emergency about in vitro diagnostics authorized by an FDA Emergency Use Authorization (EUA) to speed testing.
- FDA says the partnership was born due to confusion among the clinical laboratories over how to start using diagnostic tests granted an EUA while complying with Clinical Laboratory Improvement Amendments regulations.
While the task force will not step in to assist agencies with items that fall within their jurisdictions, the goal is for it to serve as a forum for communication between its members during public health emergencies, according to the group's charter.
"FDA knows that collaborating with our federal partners to employ our collective expertise, experiences from previous incidents, and resources will better assist in a global response," FDA device chief Jeffrey Shuren said in a statement. "We also believe that this task force could lead to more innovation for diagnostic tests as developers will see a more predictable federal regulatory response through the agencies' coordination."
An EUA by FDA allows use of an unapproved medical product or unapproved uses of approved products in an emergency to diagnose serious or life-threatening diseases caused by chemical, biological, radiological and nuclear threats when there are no adequate alternatives. For example, FDA has granted EUA to tests for Middle East Respiratory Syndrome Coronavirus, Zika and Ebola.
"TTFED is anticipated to convene at the beginning of any public health situation that is expected to involve a declaration of an emergency by the Secretary of HHS that would allow authorization of IVD assays for emergency use," the document states.
Under such an emergency, labs using an in vitro diagnostic granted an EUA must still comply with CLIA requirements.
"Timely implementation of EUA diagnostic assays in the US healthcare system is dependent upon laboratories understanding the instructions for use and applying them to the patient samples received for testing," Kate Goodrich, director of the Center for Clinical Standards and Quality and CMS Chief Medical Officer, said 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."
Work will be conducted in absence of a public health emergency as well. The task force will meet at least biannually to discuss shortcomings in the current EUA implementation system, according to the charter. Every five years the charter is to be reviewed and renewed.
"In advance of an emergency, the TTFED will work to define, refine and streamline interagency approaches for the implementation of EUA IVD assays," the charter states.
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