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03/02/2020: Lab Advisory: FDA Guidance to Develop Novel Molecular Diagnostic Tests for SARS-CoV-2
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 guidance 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 Authorization (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 webinar 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:
- CDC Coronavirus Disease 2019 (COVID-19) Laboratory Biosafety
- CDC Information for Laboratories: COVID-19
- CDC Coronavirus Disease 2019
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign-up.
- Add CDC’s Coronavirus Disease 2019 Microsite to your website for real-time content updates.
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)