UMass Medical School has been awarded grants totaling more than $100 million to coordinate the nationwide push for fast, accessible COVID-19 testing, playing a major role in the National Institutes of Health’s Rapid Acceleration of Diagnostics, or RADx, program.
UMMS has already distinguished itself as an incubator for innovative point-of-care (POC) medical technology, which provides clinical information at the site where the patient is, through the Center for Advancing Point of Care Technologies, or CAPCaT, a partnership between the Medical School and UMass Lowell.
“That center has for years been conducting national searches for small businesses, evaluating them, investing in them and helping them with clinical studies,” said David McManus, MD, professor of medicine at UMMS, co-director of CAPCaT and co-principal investigator for RADx with Bryan Buchholz, PhD, chairman and professor of biomedical engineering at UMass Lowell. “That experience is why NIH asked us to help with this COVID issue and so we stepped up.”
Chancellor Michael F. Collins said rapid, convenient, affordable testing could “change the course of the pandemic.”
The RADx initiative was launched in late April by NIH, in partnership with the Office of the Assistant Secretary of Health, the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense, and is supported by a portion of $1.5 billion in federal stimulus funding.
The goal is to expand diagnostic testing capacity for COVID-19 in the United States to about 6 million tests per day by December, a huge leap from current testing capacity of about 1 million tests per day, according to a blog post by NIH Director Francis Collins, MD, PhD, who co-authored an editorial about the project in The New England Journal of Medicine on July 22.
Broadly, RADx works like the TV show, “Shark Tank,” to identify and support promising technologies that will get more people tested more easily for the SARS-CoV-2 virus, which causes COVID-19. Dr. McManus said he was one of the “sharks” that reviews proposals and oversees administrative, scientific and strategic development among projects.
UMMS’s two major RADx grants, under the program component known as RADx Tech, include collaborating with Massachusetts General Hospital to review companies’ proposals and coordinating clinical studies and development with partners at University of California San Francisco, Emory University, Johns Hopkins University and Northwestern University. Laura Gibson, MD, associate professor of medicine, co-leads the RADx Tech Clinical Studies Core, within which the studies testing novel POC diagnostic devices in the U.S. are based. Studies are designed and vetted with the NIH, U.S. Food and Drug Administration and local research site teams.
“We need to get to a place where you get up in the morning, you’re going about your day, you brush your teeth, you’re getting your saliva sample or nasal swab, and then you run your test in your home every day to determine if you have COVID,” McManus said.
More than 600 companies have completed applications and the project team is supporting about 30 companies through grants already in different phases of development. UMMS alone is already administering 14 of these grants.
NIH announced July 31 that it is investing $248.7 million in new technologies from seven biomedical diagnostic companies, identified through RADx, to address challenges associated with COVID-19 testing.
The seven technologies use different methods and formats and can be performed in a variety of settings to meet diverse needs, according to a news release from NIH. Four of the technologies introduce innovations in laboratory-based testing technologies including next generation sequencing, CRISPR and integrated microfluidic chips that could dramatically increase testing capacity and throughput while reducing the time to receive test results. Three technologies use platforms to provide nucleic acid and viral antigen tests that can give rapid results at the point of care, such as offices, manufacturing facilities, childcare centers, nursing homes and schools. Additionally, some of the tests offer more convenient sampling, such as saliva testing.
The approaches are less cumbersome and expensive than the nasopharyngeal swab and PCR testing by laboratories, which is highly sensitive but can take days for results and additional time to transport specimens.
Another project, which is receiving RADx support through UMMS, comes from PathogenDX, an Arizona-based technology company that has developed an ultra-accurate DNA-based customized pathogen testing platform for the food, agricultural and health sectors. Grant resources will be used to increase the testing capacity of PathogenDx’s DetectX-Rv Microarray Assay of COVID-19 testing to a national level, according to a news release from the company.
PathogenDX’s product is a multiplex viral diagnostic assay for the detection of SARS-CoV-2 and is currently undergoing FDA authorization. The test is designed to deliver better sensitivity and specificity than current PCR tests, while also detecting COVID-like viruses and subsequent mutations from SARS-CoV-2. With a multiplex system, thousands of samples can be tested each day.
“The NIH and UMass Medical School partnership is an incredibly synergistic collaboration,” PathogenDX CEO Milan Patel said. “Technologies like our Detectx-Rv Microarray will be critical when facing the predicted upticks in the fall, in addition to the extra challenge of distinguishing different symptoms such as the flu and common cold, in addition to COVID-19.”
McManus said the RADx-tech progress is on track and initial results are expected by early fall.
“This is such an opportunity for us on the national stage, to be selected among all these great medical schools and centers,” said McManus. “We’re very grateful that, as it’s a team effort, everybody across the Medical School and UMass Memorial Medical Center stepped up to help.”