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RADx initiative highlighted during congressional visit to NIH campus

UMass Medical School plays key role in clinical trials to support development of rapid COVID-19 tests

Several United States senators visited the National Institutes of Health at its Bethesda, Maryland, campus on May 17 for a tour of its Vaccine Research Center and discussion of COVID-19 initiatives, including the National Institutes of Health Rapid Acceleration of Diagnostics initiative, or RADx

NIH Director Francis Collins (left) hosted U.S. senators for a tour of the NIH Vaccine Research Center and a discussion of COVID-19 initiatives, including the RADx initiative.

UMass Medical School researchers continue to play a key role in clinical trials to support development of convenient, affordable and rapid COVID-19 testing through RADx.

A team led by David McManus, MD, the Richard M. Haidack Professor in Medicine and chair and professor of medicine, and Laura Gibson, MD, associate professor of medicine, who co-leads the RADx Tech Clinical Studies Core, was awarded $123 million in 2020 to oversee the clinical studies component of point-of-care and home-based diagnostics, part of RADx Tech, with partner institutions across the country.

Among an array of RADx Tech-supported technologies on display for lawmakers were a hand-held RT-PCR device and a compact, single-use cartridge that detects viral RNA with results within 30 minutes, developed by Mesa Biotech, Inc.; and Quidel Corp.’s QuickVue At-Home COVID-19 test, which received Food and Drug Administration authorization on March 31 for home use without a prescription, according to Nathaniel Hafer, PhD, assistant professor of molecular medicine and lead investigator of RADx Tech Study Logistics Core.

An NIH-supported community health initiative using QuickVue At-Home tests and an online tool developed by CareEvolution LLC, called, “Say Yes! COVID Test,” is taking place in counties in North Carolina and Tennessee to assess the benefits of self-administered COVID-19 testing and help guide other communities in implementing frequent at-home testing programs to slow the spread of COVID-19.

Dr. Hafer said RADx Tech is about to launch a COVID-19 Test Us bank, a network of biorepositories for samples that can be used for companies developing testing technologies to test their work.

“It’s going to be really helpful to us because we’ll be able to smooth out our work and our recruitment, because you can contribute samples to a biobank at any time. And then we can dole out samples to companies or groups as they need them,” Hafer said.

Researchers will target donations of samples from people who have SARS-CoV-2 infection. Hafer said, “If you’re positive (for COVID) and you want to contribute to future research to help understand the mechanism of the disease or help test new devices, come on down and give us a nasal or saliva sample.”

In addition to UMass Medical School, biorepositories for COVID-19 studies are planned for at least five RADx Tech partner sites across the country.

People interested in participating in a RADx Tech study can learn more about and register for opportunities at the website COVID-19 Test Us - Brought to you by RADx Tech. The Test Us initiative includes studies at UMass Medical School, Emory University in Atlanta, Johns Hopkins University in Baltimore, Northwestern University in Evanston, Illinois, and several outpatient practice-based research networks across the U.S.

The RADx initiative partners with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, and the Food and Drug Administration.

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