03/02/2020: Lab Advisory: FDA Guidance to Develop Novel Molecular Diagnostic Tests for SARS-CoV-2

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

FDA Guidance to Develop Novel Molecular Diagnostic Tests for SARS-CoV-2

The Food and Drug Administration (FDA) issued new guidanceexternal icon on February 29, 2020 for laboratories to be able to develop novel coronavirus (COVID-19) molecular diagnostics tests and begin use prior to obtaining Emergency Use Authorizationexternal icon (EUA). This permits laboratories that are CLIA certified and meet requirements to perform high complexity testing to start offering severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular diagnostic testing after validation is completed as outlined in the guidance. Laboratories should submit an EUA request to the FDA within fifteen business days after validation. FDA will be hosting a webinarexternal icon to provide more information on March 2, 2020 at 3pm ET.

Clinical laboratories should contact their state health departments for guidance if they have a suspected COVID-19 case specimen. Clinical laboratories should NOT attempt viral isolation from specimens collected from COVID-19 persons under investigation (PUIs). For interim guidelines for collecting, handling, and testing clinical specimens from PUIs for COVID-19, please see the CDC Coronavirus Disease 2019 (COVID-19) website.

Online Resources:

If you have any questions, please contact us at LOCS@cdc.gov.

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: March 20, 2020