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Rising to the COVID-19 Challenge: Rapid Acceleration of Diagnostics (RADx)

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NIH Rapid Acceleration of Diagnostics (RADx) Initiative for COVID-19
Credit: NIH

Step into any major medical center, and you will see the amazing power of technology at work. From X-rays to functional MRIs, blood typing to DNA sequencing, heart-lung machines to robotic surgery, the progress that biomedical technology has made over the past century or so stands as a testament to human ingenuity—and its ability to rise to the all-important challenge of saving lives and improving health.

Today, our nation is in the midst of trying to contain a most formidable health threat: the global coronavirus disease 2019 (COVID-19) pandemic. I’m convinced that biomedical technology has a vital role to play in this urgent effort, which is why the NIH today launched the Rapid Acceleration of Diagnostics (RADx) Initiative.

Fueled by a bold $1.5 billion investment made possible by federal stimulus funding, RADx is an urgent call for science and engineering’s most inventive and visionary minds—from the basement to the board room—to develop rapid, easy-to-use testing technologies for SARS-CoV-2, the novel coronavirus that causes COVID-19. To achieve this, NIH will work closely with our colleagues at the Biomedical Advanced Research and Development Authority, the Centers for Disease Control and Prevention, and the Food and Drug Administration.

If all goes well, RADx aims to support innovative technologies that will make millions more rapid SARS-CoV-2 tests available to Americans by late summer or fall. Such widespread testing, which will facilitate the speedy identification and quarantine of infected individuals and their contacts, will likely be a critical component of making it possible for Americans to get safely back into public spaces, including returning to work and school.

For history buffs and tech geeks, the RADx acronym might ring a bell. During the World War II era, it was the brainstorming of MIT’s “Rad Lab” that gave birth to radar—a groundbreaking technology that, for the first time, enabled humans to use radio waves to “see” planes, storm systems, and many other things. Radar played such a valuable role in finding bombing targets, directing gunfire, and locating enemy aircraft, ships, and artillery that some have argued that this technology actually won the war for the U.S. and its Allies.

As for NIH’s RADx, our aim is to speed the development and commercialization of tests that can rapidly “see” if people have been infected with SARS-CoV-2 with very high sensitivity and specificity, meaning there would be few false negatives and false positives. A key part of this effort, which started today, will be a national technology development competition that’s open to all comers. In this competition, which begins a bit like a “shark tank,” participants will vie for an ultimate share of an approximately $500 million fund that will be awarded to help advance the most-promising testing technologies.

The proposals will undergo an initial review for technical, clinical, commercial, and regulatory issues. For example, could the testing technology be easily scaled up? Would it provide clear advantages over existing approaches? And would the U.S. health-care system realistically be able to adopt the technology rapidly? If selected, the proposals will then enter a three-phase process that will run into summer. Each development team will receive its own initial budget, deadlines, and set of deliverables. Competitors must also work collaboratively with an assigned expert and utilize associated web-based tools.

As you see in the graphic above, each phase will whittle down the competition. Those testing technologies that succeed in making it to Phase 2 will receive an appropriate budget to enable full clinical deployment on an accelerated timeline. They will also be matched with technical, business, and manufacturing experts to boost their chances of success.

Of course, not all technologies will enter the competition at the same stages of development. Those that are already relatively far along will be “fast tracked” to a phase that corresponds with their place in the commercialization process. Our hope is that the winning technologies will feature patient- and user-friendly designs, mobile-device integration, affordable cost, and increased accessibility, for use at the point of care (or even at home).

To assist competitors in their efforts to accomplish these bold goals, RADx will expand the Point-of-Care Technologies Research Network, which was established several years ago by NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). The network supports hundreds of investigators through five technology hubs at: Emory University/Georgia Institute of Technology, Atlanta; Johns Hopkins University, Baltimore; Northwestern University, Evanston, IL; University of Massachusetts Medical School, Worcester; and the Consortia for Improving Medicine with Innovation & Technology at Harvard Medical School/Massachusetts General Hospital, Boston.

RADx is focused on diagnostic testing, but NIH is also intensely engaged in developing safe, effective therapies and vaccines for COVID-19. One innovative effort, called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), is a public-private partnership that aims to speed the development of ways to treat and prevent this disease that’s caused so much suffering and death around the globe.

So, to the U.S. science and engineering community, I have these words: Let’s get going—our nation has never needed your skills more!

Links:

Coronavirus (COVID-19) (NIH)

NIH mobilizes national innovation initiative for COVID-19 diagnostics, NIH news release, April 29, 2020

Point-of-Care Technologies Research Network (National Institute of Biomedical Imaging and Biotechnology/NIH)

NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options, NIH news release, April 17, 2020.

We Need More COVID-19 Tests. We Propose a ‘Shark Tank’ to Get There, Lamar Alexander, Roy Blunt. Washington Post, April 20, 2020.

13 Comments

  • Leo says:

    Excellent initiative. I hope this will boost the finding of a new diagnostic and treatment for the COVID19

    • Christine Leonelli RN BSN says:

      Impressive and innovative way to include a variety of individuals in this important endeavor. Thank you for your expertise and hard work.

  • Dr. Marian Laderoute says:

    How about Fordyce spots on the inner side of the upper lip? They might identify those individuals with HERV-K102 particles pre-induced. HERV-K102 ‘trained (innate) immunity’ representing a protector foamy virus unique to humans, might play an important role in protection against RNA virus pandemics. The increased risk for COVID-19 severity appears to pertain to immunosenescence. A working definition of immunosenescence is the failed lytic release of HERV-K102 particles from foamy macrophages related to a poor DHEA/cortisol ratio.

  • SHEETAL uppal says:

    Is this competition open to international participants too?

  • DR. SAUMYA PANDEY, PH.D. says:

    Congratulations to NIH RADx summary-snapshot expert(s) with credits for accelerating the immunotherapeutics-Covid-19 field. Ethical, scientifically sound and high-quality clinical research warrants collaborative efforts from my American colleagues developing innovative protocols for patient-friendly therapeutics.
    The precision-based, high-throughput RADx should be propagated globally and adverse events post-Covid-19 investigational drug’s screening interventions with reproducible titres/cut-oofs should be unambiguously reported.
    Recently, I successfully published high-quality articles with critical research insights in the competitive physiology field, including gastrointestinal-liver-lung-molecular/cellular physiology and therefore, the current highlights about the innovative Covid-19 RADx further added to my scientific knowledge-base and professional pursuits!

  • SB says:

    Impressive and innovative way to include a variety of individuals in this important endeavor.

  • Tirsit Mogues says:

    Best wishes. I imagine and hope for a simple Litmus paper like initial testing that can done with little expertise to be followed by
    confirmation testing.

  • Richard D Borgeson says:

    I suppose it has already been discussed but if not I suggest that Coldeez may be helpful
    After all, it does reduce cold symptoms which are of course caused by viruses.

  • sbm says:

    Thanks for this article. And yeah, it is a very good article as well. Thanks for sharing this information.

  • Allon Wagner says:

    As a scientist who’s working on similar things, I couldn’t agree more. Let’s get to work!

  • Baba Manali says:

    It’s June! I think we would need Phase 2 to have commenced to meet these deadlines. Are we on track?

  • Jack Yung says:

    When can we expect a public update from NIH on progress with the RADx initiative? It’s been 35 days since this program was announced and the public has been offered no encouragement that the government is advancing this initiative in time for deployment by “late summer or early fall”. Frequent updates from NIH on RADx progress would be most welcome. Please consider a more transparent approach to communicating with the public re:RADx initiative and thank you for your continued work.

  • Nik Calgary says:

    This pandemic is a life changing event for many and is absolutely important to have an update on the progress of the plan. I appreciate periodic updates on phase 0 shortlisted companies and phase 1 development.

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