MRIGlobal Tests First Non-EUA Flu and COVID-19 Diagnostic

CDC estimates that since 2010, except for the 2020-2021 flu season, flu has resulted in between 9 million and 41 million illnesses annually in the United States. Its symptoms can include fever, chills, cough, sore throat, and runny nose. And since it was first reported in March 2020, COVID-19 has totaled more than 104 million cases in the United States. Unfortunately, when a patient gets sick with the flu or COVID-19, the symptoms of each can be very similar, making it difficult to distinguish which respiratory disease a patient has, and which therapeutic measures should be taken.

The similarity of these symptoms makes a multiplex diagnostic that can distinguish between respiratory diseases and even detect a co-infection particularly beneficial, as it can help direct the appropriate therapeutics. MRIGlobal collaborator Healgen Scientific, LLC has developed the Heal-Check Rapid COVID-19 + Influenza A/B Antigen Test, which is a multiplex diagnostic that meets this need. The Healgen test is a lateral flow assay (LFA) intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2, Influenza A, and Influenza B proteins using anterior nares nasal swab samples.

In support of their submission to the FDA and with support from the NIH Rapid Acceleration of Diagnostics (RADx®) Independent Test Assessment Program (ITAP), MRIGlobal research teams in Kansas City, MO. and Gaithersburg, MD., performed several required studies, including limit of detection, analytical, flex, and environmental studies. Utilizing the instrumentation in MRIGlobal’s laboratories at these two locations, coupled with the expertise of our researchers, our teams worked in parallel to accelerate the studies performed, which shortened the study schedule significantly. This work resulted in the first at-home diagnostic for COVID-19 and influenza to be authorized through traditional premarket review pathways.

In alignment with the MRIGlobal mission to improve people’s lives through innovative scientific and engineering research, the MRIGlobal team worked to accelerate the study process. Through strong collaboration and effective communication with project partners, including data and scheduling updates, the MRIGlobal team designed, modified, and performed studies to meet customer needs. The team’s commitment to this effort was key to prompt submission of the data to the FDA and resulting successful FDA marketing authorization.Read more about the Healgen diagnostic at “Healgen Scientific Receives FDA De Novo Marketing Authorization for At-Home COVID-19 and Influenza Test.”This project has been partly funded with federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92022D00013.