MRIGlobal Testing Supports First FDA-Cleared
Over-the-Counter COVID-19 Test
Authorization Signals Breakthrough for Infectious Disease Diagnostics
Kansas City, Mo.: (Aug. 22, 2023) – In a breakthrough for infectious disease diagnostics, MRIGlobal is proud to have conducted clinical reference testing of the first COVID-19 test to receive clearance for at-home, over-the-counter use (OTC) from the U.S. Food and Drug Administration (FDA). FDA announced June 6, 2023, that it granted De Novo authorization for the Cue COVID-19 Molecular Test, designed for both home and point-of-care use. MRIGlobal’s clinical reference testing successfully demonstrated that the Cue Health COVID-19 Molecular Test is effective in the detection and diagnosis of SARS-CoV-2 in anterior nasal swab samples.
This work began in December 2021, amid the COVID-19 pandemic, with thousands of samples being tested in MRIGlobal laboratories. While this initially supported Cue Health’s Emergency Use Authorization (EUA), the work continued through May 2023 in support of Cue’s request for De Novo authorization, resulting in the first molecular test cleared for at-home and point-of-care use and the first De Novo granted for any over-the-counter test for respiratory infections.
“The future of patient care is in at-home and point-of-care diagnostic devices. I’m proud that Cue Health, a leader in infectious disease diagnostics, entrusted our team at MRIGlobal to help support such an important achievement,” said Dr. Ian M. Colrain, President & CEO, MRIGlobal. “Cue Health has a history of accuracy, speed, and innovation, and we look forward to ongoing collaboration in support of diagnostic tools that continue to improve detection and diagnosis for consumers around the world.”
“At Cue, we hold our diagnostic tools to the highest standards of accuracy and reliability, and MRIGlobal helped ensure that our COVID-19 test met that objective through rigorous clinical research,” said Andy Hudak, Senior Vice President of R&D and Program Management at Cue Health. “Our De Novo authorization was an extremely important milestone for Cue, and we’re proud that our platform continues to provide individuals and providers with timely and actionable information that can help improve health outcomes.”
MRIGlobal has capabilities in its CAP/CLIA (indicates certification by the College of American Pathologists/Clinical Laboratory Improvement Amendments) laboratory in Kansas City, Missouri, which features a unique combination of instrumentation and operational readiness, enabling the company to promptly and accurately support client EUA, De Novo, and 510(k) submissions for FDA clearance. Since the onset of the COVID-19 pandemic, MRIGlobal has provided its analytical and CAP/CLIA clinical facilities and expertise, with a history of successful EUA approvals and 510(k) submissions. Coupled with our extensive past experience working with SARS, MERS, Ebola, mpox, malaria, and other highly infectious diseases, MRIGlobal is well-positioned to support a wide range of customer needs that address future infectious disease threats.
# # #
MRIGlobal improves the health and safety of people everywhere by addressing some of the world’s greatest threats and complex biological, chemical, and engineering challenges. Founded in 1944 as an independent, not-for-profit organization, MRIGlobal provides customized research and development services to health and defense-focused organizations in need of innovative and multidisciplinary solutions. This includes expertise in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. To learn more, visit mriglobal.org.