Co-Diagnostics, Inc.'s new Co-Dx PCR Home platform backed by NIH RADx Tech program
Funds will aid in the completion of its upper respiratory panel multiplex on Co-Dx PCR Home platform
7 Aug 2023Co-Diagnostics, Inc., a molecular diagnostics company with a patented platform for the development of molecular diagnostic tests, has announced that it has been awarded $1.2 million 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 to complete the 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 testing platform. 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.
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.
The Co-Dx PCR Home testing platform and its associated tests are subject to FDA review and are not available for sale.