MRIGlobal Research Part Of First COVID-19 Test Approved For At-Home Use Without A Prescription

MRIGlobal played a key role in achieving approval for the first SARS-CoV-2 diagnostic molecular test authorized for consumer at-home use without a prescription.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue OTC Test), developed by Cue Health, Inc., received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 5.

As a contract vendor, MRIGlobal was responsible for the live virus testing to support Cue Health's EUA submission for FDA approval. Testing included feasibility, LOD, sensitivity, stability and interference. MRIGlobal also conducted infectious disease panel testing, including genomic analysis of several infectious disease agents to help troubleshoot cross reactivity. In addition, MRIGlobal provided the reference lab testing to support the EUA OTC claim and FDA submission.

About MRIGlobal

MRIGlobal addresses some of the world's greatest threats and challenges. Founded in 1944 as an independent, non-profit organization, we perform contract research for government, industry, and academia. Our customized solutions in national security and defense and health include research and development capabilities in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. MRIGlobal is one of two partners in the Alliance for Sustainable Energy, LLC, which manages and operates the National Renewable Energy Laboratory (NREL) in Golden, Colorado, for the U.S. Department of Energy.