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.