Co-Diagnostics, Inc. announced today that its Logix Smart™ Influenza A/Influenza B/COVID-19 “ABC” Test has been approved for sale in Mexico by the Mexican Department of Epidemiology (“InDRE”) after InDRE successfully concluded an independent evaluation of the test’s sensitivity and specificity for use as an RT-PCR multiplex test in that market.
InDRE, which is analogous to the U.S. Centers for Disease Control and Prevention (CDC), is required to evaluate any test used to detect COVID-19 before the test may gain clearance to be sold into the Mexican healthcare market.
Since being granted its CE marking last year, we have seen demand increase for our high-quality ABC multiplex diagnostic. We expect that the ability to accurately and reliably differentiate between influenza A/B and COVID-19 will grow in importance after predictions by experts like the CDC that reduced population immunity due to lack of flu virus activity last year may now result in a severe flu season.
We believe that the Mexican approval and clearance in such an important healthcare market serves as further validation of the quality of our CoPrimer™ platform, and our commitment to increasing access to affordable, state-of-the-art diagnostics products around the world.Dwight Egan, CEO of Co-Diagnostics