Federal task force to help develop, deploy emergency diagnostics

The Food and Drug Administration, Centers for Disease Control and Prevention and Centers for Medicare & Medicaid Services today launched the Tri-Agency Task Force for Emergency Diagnostics, which will work to rapidly develop and deploy diagnostic tests to clinical and public laboratories in an emergency. “Timely implementation of [emergency use authorization] 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 Kate Goodrich, CMS chief medical officer and director of the Center for Clinical Standards and Quality. “As part of this task force, it is our goal to provide clear and consistent guidance to laboratories on the application of [Clinical Laboratory Improvement Amendments] requirements for these emergency assays.”