Range of new technologies will meet testing needs in diverse settings.
The National Institutes of Health is investing $248.7 million in new technologies to address challenges associated with COVID-19 testing (which detects SARS-CoV-2 coronavirus). NIH’s Rapid Acceleration of Diagnostics (RADx) initiative has awarded contracts to seven biomedical diagnostic companies to support a range of new lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by millions per week as early as September 2020. With national demand estimated to be millions more tests per day above current levels, these technologies are expected to make a significant contribution to expanding the nation’s testing capacity.
“RADx moved incredibly quickly to select promising technologies through its ‘shark tank’ approach, investing in technologies that could boost America’s best-in-the-world COVID-19 testing capacity by millions more tests per day,” said HHS Secretary Alex Azar. “These technologies will help deliver faster results from labs and more and more test results within minutes at the point of care, which is especially important for settings like schools and nursing homes.”
Mesa Biotech’s Accula SARS-CoV-2 test can produce results in 30 minutes. Credit: Mesa Biotech
The seven technologies use different methods and formats and can be performed in a variety of settings to meet diverse needs. 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 companies range in scope from small start-ups to large publicly held organizations. The U.S. Food and Drug Administration has been working with NIH and RADx external advisors to provide general advice on test validation and is prioritizing the review of emergency use authorization (EUA) for tests supported by RADx. The companies awarded today have either received EUA from the FDA for their COVID-19 test or have applications in process.
“The RADx initiative has enabled some of the nation’s most creative biomedical device inventors to ramp up development of their testing technologies at unprecedented speed,” said NIH Director Francis S. Collins, M.D., Ph.D. “The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.”
NIH launched RADx on April 29, 2020, just days after receiving an emergency supplemental appropriation of $1.5 billion from Congress to support innovative technologies to make millions of rapid COVID-19 tests per week available to Americans by the fall. At that time, Dr. Collins issued a nationwide call to science and engineering’s most innovative minds. An overwhelming response ensued, culminating in more than 650 applications to date.
Hundreds of experts from government, academia and industry, including the National Institute of Biomedical Imaging and Bioengineering’s (NIBIB) Point-of-Care Technology Research Network (POCTRN), are contributing to the RADx process by evaluating applications, providing core technical and clinical resources and guiding project teams. NIH selected approximately 100 of the best concepts to enter an intense one-week “shark-tank” technology evaluation process. Thirty-one of these projects made the cut and moved to Phase 1, a rigorous four to six-week period of initial technology validation. The seven tests announced today are the first to be chosen for scale up, manufacturing and delivery to the marketplace through RADx. More than 20 companies remain actively engaged in meeting Phase 1 milestones and will be considered for Phase 2 awards in the coming weeks. In addition, dozens of promising concepts continue to move through the RADx “innovation funnel” and may be selected for Phase 1 and/or Phase 2 funding.
“This is an exciting milestone,” said Bruce J. Tromberg, Ph.D., director of NIBIB and leader of RADx Tech, one of four components of the NIH RADx initiative. “It will increase U.S. testing capacity exponentially over the next few months. These and other technologies emerging from our RADx pipeline will guide patient care and inform public health measures to stop the spread of the virus and leave us better equipped to address future pathogens and other diseases.”
The following companies have achieved key RADx milestones and will receive support for manufacturing and scale up.
The company’s Accula SARS-CoV-2 test employs a hand-held RT-PCR device and a compact, single-use cartridge that detects viral RNA at the point of care. Results can be read from the removable cartridge in 30 minutes.
The Quidel Sofia SARS Antigen FIA test kit, a lateral flow immunoassay, is used with Sofia and Sofia 2 Analyzers in point of care settings, such as a doctor’s office or pharmacy. There are currently thousands of Quidel analyzers in place across the United States and HHS has identified this technology for use in nursing homes. The analyzers give electronic results within 15 minutes.
Talis Biomedical, Menlo Park, California The Talis One COVID-19 point of care test is a multiplexed cartridge used with the compact Talis One instrument. The test detects SARS-CoV-2 through isothermal amplification of viral RNA and an optical detection system, returning a result in under 30 minutes.
Ginkgo Bioworks is scaling up using significant automation for handling samples and high-throughput, next-generation sequencing technologies to process tens of thousands of individual tests at once. Working with universities, schools, public or private companies, and local communities, Ginkgo Bioworks will provide end-to-end sample collection and report results within 24-48 hours from sample receipt. The company is expected scale up to 50,000 tests per day in September 2020 and 100,000 per day by the end of the year.
Helix will ship standardized kits in bulk for the collection of nasal swabs to public health departments, health care systems, employers and other customers to collect tens of thousands of samples that can be processed at once and within 24-48 hours, in very high volumes, using a combination of sophisticated automation processes and the use of next generation sequencing technologies. Helix is expected to process up to 50,000 samples a day by end of September 2020 and 100,000 samples per day at the end of the year.
Each BioMark HD microfluidics platform has the capacity to process thousands of SARS-CoV-2 PCR tests per day with a primary focus on saliva samples. With many existing Fluidigm instruments in clinical and research labs throughout the United States, scale up and deployment of their advanced integrated fluidic chips can provide tens to hundreds of thousands of new tests per day in fall 2020.
The Mammoth Biosciences SARS-CoV-2 DETECTR assay uses CRISPR technology, which provides a simpler workflow and significantly faster turnaround time compared to conventional laboratory PCR tests. This high-throughput solution can result in a multi-fold increase in testing capacity in commercial laboratories.
About RADx: RADx Tech and RADx Advanced Technology Program leverage the Point-of-Care Technology Research Network (POCTRN) administered by NIBIB and spanning multiple leading universities, in order to manage, evaluate, and validate technologies. In addition, RADx partnerships with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, and FDA play a critical role in program operations and, in some cases, joint project support.
About the National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. NIBIB supports emerging technology research and development within its internal laboratories and through grants, collaborations, and training.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.