UMass Medical School and UMass Lowell will perform a key role in a new National Institutes of Health initiative aimed at speeding innovation, development and commercialization of COVID-19 testing technologies via their Center for Advancing Point of Care Technologies collaboration.
With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing.
CAPCaT, a product of the Massachusetts Medical Device Development Center (M2D2) at the University of Massachusetts Lowell and Medical School campuses, will support projects to develop and optimize novel point of care technologies to improve the diagnosis and management of disease—a key component of the RADx initiative.
CAPCaT is one of four centers across the country in the National Institutes of Health Point-of-Care Technologies Research Network (POCTRN), which was created in 2018 to help revolutionize patient care; it assists inventors developing technologies and medical devices to help patients with blood, heart, lung and sleep conditions manage their well-being wherever they are.
Innovations supported by CAPCaT are devices and technologies well on their way to going to market. Products already being developed at CAPCaT include a product to help critically ill infants sleep better, an online education program for patients to manage hypertension, and a portable device that can evaluate how the user’s platelets are performing. The center also seeks to support technologies that promote holistic methods of managing diseases, including devices that measure stress levels or promote mindfulness.
The CAPCaT team has the skills including engineering, business development, clinical trial and statistical analysis, resources and network necessary to develop a successful COVID-19 grant program focused on identifying, implementing and funding promising point-of-care technology research on an expedited timeline, according to David McManus, MD, professor of medicine at UMMS. McManus co-directs CAPCaT along with Prof. Bryan Buchholz, Ph.D., chairman of the Department of Biomedical Engineering at UMass Lowell.
“The technical expertise of UMass Lowell’s researchers will be invaluable to identify, support and validate safe and accurate diagnostics for COVID-19,” said Buchholz. “Together with the clinical experience UMass Medical School brings to the table, we are ready to do our part in defeating this devasting disease.”
CAPCaT will conduct a rapid needs assessment regarding point of care technology needs related to the COVID-19 pandemic for RADx and then solicit and review proposals that offer potential solutions; recommend funding for clinical validation of these solutions and move them through the commercialization pipeline and into practice; and keep the research and clinical communities informed about COVID-19 needs, opportunities and resources.
According to the NIH, while diagnostic testing has long been a mainstay of public health, newer technologies offer patient- and user-friendly designs, mobile-device integration, reduced cost and increased accessibility both at home and at the point of care.
RADx will expand POCTRN to use a flexible, rapid process to infuse funding and enhance technology designs at key stages of development, with expertise from technology innovators, entrepreneurs and business leaders across the country. POCTRN supports hundreds of investigators from multiple universities and businesses through four technology hubs in addition to the University of Massachusetts: Emory University/Georgia Institute of Technology; Johns Hopkins University; Northwestern University, Evanston; and the Consortia for Improving Medicine with Innovation & Technology (CIMIT) at Harvard Medical School/Massachusetts General Hospital.
As part of RADx, NIH is urging all scientists and inventors with a rapid testing technology to compete in a national COVID-19 testing challenge for a share of up to $500 million over all phases of development. The technologies will be put through a highly competitive three-phase selection process to quickly identify the best candidates for at-home or point-of-care tests for COVID-19. Finalists will be matched with technical, business and manufacturing experts to increase the odds of success. If certain selected technologies are already relatively far along in development, they can be put on a separate track and be immediately advanced to the appropriate step in the commercialization process. The goal is to make millions of accurate and easy-to-use tests per week available to all Americans by the end of summer 2020 and even more in time for the flu season.
Led by the Coordinating Center at CIMIT, the network has assembled expert review boards covering scientific, clinical, regulatory and business domains that will rapidly evaluate technology proposals. In order to roll out new products starting at the end of summer/fall 2020, a rapid, parallel process will allow quick throughput of projects. Projects will be assessed at each milestone and must demonstrate significant progress to receive continued support.