IEEE, the world's largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Engineering in Medicine and Biology Society (EMBS), have released a series of reports detailing methodology for developing breakthrough COVID-19 testing techniques based on guidelines and funding provided by the U.S. National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx). The reports are published in a special issue of IEEE Open Journal of Engineering in Medicine and Biology, which is freely available for download and full-text viewing by all readers worldwide.
NIH launched RADx a year ago to speed the development, validation, and commercialization of innovative point-of-care and home-based tests for detecting SARS-CoV-2, the virus at the root of the COVID-19 pandemic. Through RADx, NIH issued a call to scientists and organizations for approaches making testing more accessible, more accurate, and easier to use.
During RADx Tech’s first seven months, more than 700 applications were evaluated, and, by March 2021, RADx Tech-supported companies had established capacity to potentially produce up to 1.9 million tests per day. Funded RADx Tech projects fueled new applications of existing technologies, as well as accelerated development of new diagnostic technologies. Though it typically takes three to seven years to bring medical devices (including diagnostics) to market, the U.S. FDA had granted Emergency Use Authorization (EUA) to 19 tests by late April 2021, including the first over-the-counter test for use at home.
The reports included in the IEEE Open Journal of Engineering in Medicine and Biology special issue span the range of operational details vital to RADx Tech’s success: Software platforms that enabled the program’s infrastructure and processes; Expert review panels; Unique facilitation provided to the funded applicants; Point-of-Care Technologies Research Network (POCTRN) Cores used to evaluate technologies at the bench top early stage of their design and in their actual use; Support for large-scale manufacturing and deployment of diagnostic tests; and Impact of RADx Tech on future med-tech entrepreneurs and developers.
Click here to read the original press release.
