BioPhotonics spoke with Bruce Tromberg, the director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) within the National Institutes of Health (NIH), where he oversees research programs focused on developing, translating, and commercializing engineering, physical science, and computational technologies in biology and medicine. In addition, Tromberg leads NIBIB’s $500 million Rapid Acceleration of Diagnostics (RADx) initiative to substantially increase SARS-CoV-2 testing capacity and performance (www.nih.gov/research-training/medical-research-initiatives/radx). He is also a leader of Operation Warp Speed, a program initiated by the federal government to facilitate and accelerate development of COVID-19 vaccines, therapeutics, and diagnostics.

What is the role of the biophotonics community in the effort to expand testing and ultimately find a cure for COVID-19?

There is an enormous amount of energy and talent in our community, and there are many diagnostic strategies, platforms, and devices out there. Because there are different testing needs for different situations, a big challenge is to figure out how to match test technical performance with the various user communities who need testing. For example, there are tests that can be performed in complex lab settings, at the point of care, and in the home. And these tests need to be administered to people with symptoms as well as asymptomatic people in many different places: schools, nursing homes, places of employment, transportation hubs, etc.

The optics and photonics community has people working on improving the technical performance of diagnostic technologies in many ways, spanning from optimizing molecular and nanoparticle reporters and probes to developing dedicated optics/photonics readers and smartphones. We are seeing important innovations in these areas that come from research institutions and companies big and small. As these innovations are de-risked, we will need established companies with large-scale manufacturing and distribution networks to expand these platforms to produce and deliver the tests that the world needs.

How will NIBIB fit into the combined effort represented by Operation Warp Speed?

Operation Warp Speed really represents an effort to integrate the expertise we have across the government, including NIH, FDA, DOD, CDC (Centers for Disease Control and Prevention), ASPR/BARDA (Assistant Secretary for Preparedness and Response and Biomedical Advanced Research and Development Authority), and even FEMA (Federal Emergency Management Agency). From the NIH’s perspective, for the last 13 years, we have developed and utilized the Point-of-Care Technologies Research Network (POCTRN), which includes five major institutional hubs: Emory University and the Georgia Institute of Technology; Johns Hopkins University; Northwestern University; the University of Massachusetts Medical School in Worcester and the University of Massachusetts Lowell; and the Consortia for Improving Medicine with Innovation & Technology at Harvard Medical School and Massachusetts General Hospital. But there are many other institutions and companies that work in conjunction with these centers.

When $500 million was appropriated for testing by Congress on April 24, NIBIB was able to launch a new program, Rapid Acceleration of Diagnostics (RADx), in only five days because of the existing POCTRN structure. RADx supports both traditional laboratory and point-of-care approaches, and the overall goal is to expand testing capacity by about thirty- to fiftyfold versus what existed back in the middle of April, when we were only conducting about 150,000 tests per day in the U.S.

What will the next several months of this initiative look like?

I am happy to report that things have already improved a lot since mid-April. We have more than 450 proposals in various stages of evaluation and development in our innovation pipeline. Many are using state-of-the-art optical components and sensing technology. Applications are coming from more than 40 states, including from small, medium, and large companies; startups; academic groups; and some nonprofits. One of the unique aspects of the RADx review process is the deep dive, or “Shark Tank,” phase, where each applicant team is matched up with a group of about six experts for a full week of intensive feedback. As projects are evaluated and move forward, key steps along the way include technical validation, clinical performance assessment, regulatory clearance, manufacturing, scale-up, and commercialization/market plans.

For more information, visit www.poctrn.org/radx.