Putting COVID-19 Tests to the Test

Fast, cheap and easy. They are not words typically associated with the field of biomedical engineering. 

However, when it comes to mass testing for SARS-CoV-2 — the virus that causes COVID-19 — fast, cheap and easy are the goals. Without sacrificing safety, of course. 

Faculty and students from the Biomedical Engineering Department are playing a key role in dramatically ramping up testing capacity for COVID-19 through their work on RADx, or the Rapid Acceleration of Diagnostics, a National Institutes of Health (NIH) initiative. 

Launched in April with $1.5 billion in federal stimulus funding, RADx aims to fast-track the efforts of scientists, inventors and companies to develop and commercialize COVID-19 tests that are quick, accurate and widely accessible. The goal is to make 6 million tests available each day in the United States by December. 

“Time is of the essence. We are trying to get as many of these tests out there as soon as possible,” says Prof. Bryan Buchholz, chair of the department and co-principal investigator for RADx with David McManus, professor of medicine at UMass Medical School. 

Buchholz and McManus are co-directors of the Center for Advancing Point of Care Technologies (CAPCaT), an NIH-funded partnership between UML and UMass Medical School and a product of the institutions’ joint venture, the Massachusetts Medical Device Development Center (M2D2). 

Because CAPCaT already provides grants and guidance to inventors developing technologies and medical devices to help patients with blood, heart, lung and sleep conditions, Buchholz says it was a natural fit to take on the RADx work. 

“It was fairly straightforward for NIH to mobilize that infrastructure, and I knew through the Biomedical Engineering Department that we could build the testing capability fairly quickly,” says Buchholz, whose team’s first task was to set up a test verification lab at the university’s Innovation Hub at 110 Canal Street in downtown Lowell. 

There, the RADx team puts proposed diagnostic methods to the test. Primarily using inactivated SARS-CoV-2 samples, they evaluate the accuracy and sensitivity of the tests. If a company’s test is validated, it advances to Phase 2 and can apply for emergency use authorization from the U.S. Food and Drug Administration. 

“When we get a hold of the test, we want to be able to get back to the manufacturer or developer as quickly as we can with the results and say, ‘Yes, this works. Go forward with it,’ or ‘We are seeing these problems. Can you tweak a bit?’” Buchholz says. 

In the first three months, more than 600 developers of rapid test technologies applied for a share of $500 million in funding from RADx, which puts them through a highly competitive “Shark Tank”-style approval process. As one of five centers across the country that make up the NIH’s Point-of-Care Technologies Research Network, CAPCaT is a secondary RADx testing site and has worked with a half-dozen companies as of this fall. 

One of those companies, Quanterix in Billerica, Massachusetts, announced in early October that it had received an $18.2 million Phase 2 contract from RADx to accelerate the continued development, scale-up and deployment of its antigen test. 

For the two biomedical engineering students on the RADx team — undergraduate Devon Hartigan and graduate student Anyelo Diaz ’17 — it is an extraordinary opportunity to be involved with a project aimed at curbing a global pandemic.

 “I never would have expected that I would be in this level of research,” says Hartigan, a sophomore from Natick, Massachusetts. She was invited to join the team by Asst. Prof. of Biomedical Engineering Chiara Ghezzi, who is leading the lab-based verification efforts. 

Hartigan has been part of Ghezzi’s lab since her first year, working on engineering corneal replacements based on natural polymers. With RADx, Hartigan finds herself working with inactivated strains of the world’s most notorious virus, validating potential testing products before they can receive Phase 2 NIH funding to scale up. 

“I have learned a lot about what goes into the approval of these diagnostic tests. Each step is very complicated, and we have to work together to get through them and understand them,” Hartigan says. 

Diaz, who earned a bachelor’s degree in biology from UML and now works in Ghezzi’s lab, says being part of the RADx team is providing him with invaluable hands-on experience. 

“This experience is going to help me a lot in my career,” says Diaz, a native of the Dominican Republic. “Besides the lab component of testing the technology, I am learning how to manage a project from beginning to end, how to create standard operating procedures, how to resolve problems.” 

Most of the tests the team has been evaluating detect viral RNA using a technique called polymerase chain reaction. It is complex work at the molecular level, Diaz says, “but if you break things apart, piece by piece, it does not seem that complex.” 

RADx is an interdisciplinary effort, as well. Denise Dunlap, an assistant professor in the Manning School of Business, is analyzing the companies that apply for funding and the network involved in their selection. 

“I am proud of the people that are part of this team and the work that everybody is doing,” Buchholz says. “It is definitely gratifying to be doing something that is fighting this deadly pandemic and showing the world that our Biomedical Engineering Department has these capabilities.”