The National Institutes of Health is investing $248.7 million in new technologies to address the challenges associated with COVID-19 testing (which detects the SARS-CoV-2 coronavirus). The NIH’s Rapid Acceleration of Diagnostics (RADx) initiative has awarded contracts to seven biomedical diagnostics companies to support a range of new laboratory and point-of-care tests that could significantly increase the number, type, and availability of tests by millions per week beginning in 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 capacity. of tests in the country.
“RADx moved incredibly quickly to select promising technologies through its ‘shark tank’ approach, investing in technologies that could increase the world’s best COVID-19 testing capacity by millions more tests per day,” said HHS Secretary Alex Azar. “These technologies will help get faster results from laboratories and increasingly test results within minutes at the point of care, which is especially important for settings like schools and nursing homes.”
The seven technologies use different methods and formats and can be performed in a variety of environments to meet various needs. Four of the technologies introduce innovations in laboratory 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 provide rapid results at the point of care, such as offices, manufacturing facilities, daycares, nursing homes and schools. Additionally, some of the tests offer more convenient sampling, such as the saliva test. The scope of the companies varies from small start-ups to large public organizations. The US Food and Drug Administration has been working with outside advisors from NIH and RADx to provide general advice on test validation and is prioritizing review of emergency use authorization (EUA) for RADx-supported tests. The companies honored today have received an EUA from the FDA for their COVID-19 test or have applications in process.
“The RADx initiative has enabled some of the country’s most creative biomedical device inventors to accelerate the development of their testing technologies at unprecedented speed,” said NIH Director Francis S. Collins, MD, Ph.D. “The innovations selected to date represent the various types of promising technologies that will meet the country’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 available to Americans per week by the fall. At that time, Dr. Collins issued a nationwide call for the most innovative minds in science and engineering. There was an overwhelming response culminating in over 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, week-long “shark tank” technology evaluation process. Thirty-one of these projects made the cut and moved on to Phase 1, a rigorous four- to six-week period of initial technology validation. The seven tests announced today are the first chosen for scale-up, manufacturing and delivery to market 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. Additionally, dozens of promising concepts continue to advance 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 exponentially increase US testing capacity in the coming months. These and other technologies emerging from our RADx portfolio 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 manufacturing and scale-up support.
Point-of-care testing
Mesa Biotech, San Diego
The company’s Accula SARS-CoV-2 test employs a portable RT-PCR device and a compact, single-use cartridge that detects viral RNA at the point of care. Results can be read on the removable cartridge within 30 minutes.
Quidel, San Diego
The Quidel Sofia SARS Antigen FIA Test Kit, a lateral flow immunoassay, is used with the Sofia and Sofia 2 analyzers in care settings such as a doctor’s office or pharmacy. There are currently thousands of Quidel analyzers installed across the United States and HHS has identified this technology for use in nursing homes. The analyzers give electronic results in 15 minutes.
Talis Biomedical, Menlo Park, California
The Talis One COVID-19 Point-of-Care Test is a multiplexed cartridge for use with the compact Talis One instrument. The test detects SARS-CoV-2 using isothermal amplification of viral RNA and an optical detection system, returning a result in less than 30 minutes.
Laboratory tests
Ginkgo Bioworks, Boston
Ginkgo Bioworks is scaling up using significant sample handling automation and high-throughput next-generation sequencing technologies to process tens of thousands of individual tests at a time. 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 to 48 hours of receiving the sample. The company is expected to ramp up to 50,000 tests per day in September 2020 and 100,000 per day by the end of the year.
Helix OpCo, San Mateo, California
Helix will ship standardized bulk nasal swab collection kits to public health departments, healthcare systems, employers and other customers to collect tens of thousands of samples that can be processed at once and within 24 to 48 hours, at 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 per day by the end of September 2020 and 100,000 samples per day by the end of the year.
Fluidigm, South San Francisco
Each BioMark HD microfluidic 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 laboratories across the United States, the scale-up and deployment of its advanced integrated fluidic chips can provide tens to hundreds of thousands of new tests per day in fall 2020.
Mammoth Biosciences, Inc., South San Francisco, California
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 multiple increase in testing capacity in commercial laboratories.
About RADx: RADx Tech and the RADx Advanced Technology Program leverage the Point-of-Care Technology Research Network (POCTRN), managed by NIBIB and spanning multiple leading universities, to manage, evaluate and validate technologies. Additionally, RADx’s partnerships with federal agencies, including the Office of the Assistant Secretary for Health, the Department of Defense, the Biomedical Advanced Research and Development Authority, and the FDA, play a critical role in program operations and, in some cases, joint support of projects.
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 biological sciences to advance basic research and healthcare. NIBIB supports research and development of emerging technologies within its internal laboratories and through grants, collaborations and training. More information is available on the NIBIB website: https://www.nibib.nih.gov
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 that conducts and supports basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures of common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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