IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Engineering in Medicine and Biology Society (EMBS), today announced the release of 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 today 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 around the world.
NIH launched RADx one year ago today 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.1
“NIH’s RADx Tech program, highlighted in these reports, has turbocharged the development, scale-up, and deployment of powerful testing platforms. Together, the reports provide a unique view of how our innovation and entrepreneurial community has responded with unprecedented speed and impact at a time of great public urgency,” said Bruce Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering and leader of the RADx Tech program. “Accessible screening and surveillance testing will continue to help us manage COVID while providing essential new capabilities for responding to future pathogens, variants and other diseases.”
The reports included in the IEEE Open Journal of Engineering in Medicine and Biology special issue released today 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 benchtop early stage of their design and in their actual use
- Support for large-scale manufacturing and deployment of diagnostic tests
- Impact of RADx Tech on future med-tech entrepreneurs and developers
“In spite of the many constraints imposed by the COVID-19 pandemic, the national RADx Tech initiative has established a new paradigm for medical technology development and a validated model for addressing future healthcare emergencies globally,” said Dr. Steven C. Schachter, IEEE EMBS member and Guest Editor for the special journal issue; RADx Chief for the POCTRN Coordinating Center, Consortia for Improving Medicine with Innovation & Technology; and Professor of Neurology at Harvard Medical School, Boston. “RADx Tech has been unprecedented from multiple perspectives—its tremendous scope and scale, how quickly it translated inventive ideas into real-world clinical practice and the extent of collaboration achieved across government, industry and academia, for example. These papers document and make accessible the lessons learned and proven best practices that can be leveraged to save lives in the future during national healthcare emergencies.”
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About the IEEE Engineering in Medicine and Biology Society
The IEEE Engineering in Medicine and Biology Society (EMBS) is the world’s largest international society of Biomedical Engineers. With more than 9,500 members residing in some 97 countries around the world, it’s a true global connection, providing access to the most fascinating people, practices, information, ideas, opinion and fellowship from one of science’s fastest growing fields: biomedical engineering. From formalized mathematical theory through experimental science, from technological development to practical clinical applications, IEEE EMBS members support scientific, technological, and educational activities as they apply to the concepts and methods of the physical and engineering sciences in biology and medicine. By working together, we can transform and revolutionize the future of medicine and healthcare. For more information about the IEEE EMBS, please visit www.embs.org.
About the IEEE Open Journal of Engineering in Medicine and Biology
The IEEE Open Journal of Engineering in Medicine and Biology covers the development and application of engineering concepts and methods to biology, medicine and health sciences to provide effective solutions to biological, medical and healthcare problems.