The Company intends to use the funds awarded by the National Institutes of Health for completion of its upper respiratory panel multiplex on Co-Dx PCR Home™ platform
Co-Diagnostics, Inc. (Nasdaq: CODX) (the “Company” or “Co-Dx”), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that it has been awarded $1.2 million in funding from the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for completion of its upcoming upper respiratory panel on the Company’s Co-Dx PCR Home™ testing platform.
Co-Diagnostics will utilize the funds from the RADx Tech award to complete development of its flu A/B, COVID-19, and RSV multiplex test, preparatory for that test to begin clinical trials on the Co-Dx PCR Home. The Co-Dx PCR Home is currently undergoing clinical evaluations in anticipation of its submission to the FDA and an initial product launch for a COVID-19 test.
“We are pleased that the innovation and potential of our new Co-Dx PCR Home platform has been recognized by the highly competitive RADx Tech program, with its focus on accessibility and ease of use for over-the-counter and point-of-care COVID-19 diagnostic solutions,” remarked Dwight Egan, CEO of Co-Diagnostics. “This award is the result of a monumental effort on behalf of our team that involved a thorough analysis by industry experts into all aspects of the platform, its design, history, chemistry of the reagents, and the team responsible for making our vision a reality.
“Our mission to improve the quality of life through making high-quality, affordable diagnostics more available worldwide will be one step closer with the completion of this in-demand respiratory multiplex, which we believe meets the NIH’s standards for increased accessibility of next-generation testing as we navigate this post-pandemic landscape.”
The NIH launched the RADx initiative on April 29, 2020, with the goal of speeding innovation in the development, commercialization, and implementation of technologies for COVID-19 testing, leveraging the existing NIH Point-of-Care Technology Research Network. The RADx Tech program is managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), to support the accelerated development of tests and provide regulatory guidance during the COVID-19 pandemic and beyond.
This project has been funded in part with federal funds from the National Institute of Biomedical Imaging (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92023D00001.
The Co-Dx PCR Home testing platform and its associated tests are subject to FDA review and are not available for sale.