The National Institutes of Health, in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), today announced a third round of contract awards for the scale-up and manufacturing of new COVID-19 testing technologies. the six new Rapid Acceleration of Diagnostics (RADx) Initiative The contracts total $98.35 million for point-of-care and other novel testing approaches that provide new modes of sample collection, processing and return of results. Innovations in these new technologies include integration with smart devices, mobile laboratory processing that can be deployed in COVID-19 hotspots, and test results are available within minutes.
These awards are part of the RADx technology programfocused on the rapid advancement of early testing technologies. RADx Tech and RADx Advanced Technology Platforms (RADx-ATP), the latter for late-stage expansion projects, now support a combined portfolio of 22 companies totaling $476.4 million in manufacturing expansion contracts. These six additional technologies are expected to add up to 500,000 tests per day to US capacity by the end of 2020 and one million tests per day in early 2021. Combined with previous contracts announced in July and SeptemberThe RADx Tech and RADx-ATP contracts are expected to increase testing capacity by 2.7 million tests per day by the end of 2020.
“Since its launch in April, the NIH RADx initiative has moved rapidly to facilitate the critical expansion of early- and late-stage testing technologies, as well as research to remove barriers to testing for vulnerable and underserved populations,” said NIH Director Francis S. Collins, MD, Ph.D. “Each of the technologies emerging from RADx will play a critical role in expanding testing accessibility in diverse environments.”
The latest group of test technologies have been optimized and evaluated within the NIH RADx Tech development process and have met rigorous advancement criteria. Factors such as speed, accuracy, cost, and accessibility are key considerations for RADx support. RADx provides financial support and expertise to help companies meet milestones for U.S. Food and Drug Administration (FDA) clearance, expansion, and commercialization.
“The current round of awards supports five technologies that can be applied to the point of care and a powerful laboratory test,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and leader of RADx Tech, one of four programs in the NIH RADx initiative. “Technologies include an antigen test that provides results in 15 minutes, a viral RNA test deployed on mobile vans that can travel to COVID hotspots, and tests that only require saliva, nasal swabs, or blood from a finger prick.”
BARDA, part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provided funding for these RADx Tech contracts from emergency supplemental allocations to the Public Health and Human Services Emergency Fund. BARDA has contributed substantially to the country’s COVID testing capacity with support for the development of 30 SARS-COV-2 diagnostic tests since March, 15 of which have obtained emergency use authorization (EUA) from the FDA. Five of the 30 tests can distinguish between influenza and SARS-COV-2, the virus that causes COVID-19, from the same sample, and two of them achieved EUA. To date, BARDA’s industry partners have shipped more than 45 million tests to healthcare providers nationwide.
“With RADx we are expanding our long-standing partnership with the NIH to bring essential technology to the American people in the fight against COVID-19,” said BARDA Acting Director Gary L. Disbrow, Ph.D. “Our people at BARDA are bringing our expertise and experience in advanced development, manufacturing and scale-up to help us get as many rapid and accurate tests as possible as quickly as possible.”
The following companies have achieved key RADx Tech milestones and will receive manufacturing and scale-up support:
Viral antigen detection
Ellume USA LLC, Valencia, California
Two unique test cartridges contain a single-use digital fluorescent immunoassay antigen test that delivers accurate results in 15 minutes or less. Healthcare professionals can read a test nasal swab cartridge on two platforms, at the point of care or in laboratory settings for higher throughput. A second cartridge is being developed for home use with a self-administered nasal swab.
Luminostics, Inc., Milpitas, California
A rapid, smartphone-readable antigen immunoassay that uses glow-in-the-dark nanomaterials to sensitively and specifically detect SARS-CoV-2 from shallow nasal swabs in 30 minutes or less, first for point-of-care use and then for home use.
Quanterix, Billerica, Massachusetts
A laboratory antigen test with ultra-sensitive single-molecule immunoassay technology that allows detection from a variety of sample types, including nasopharyngeal blood, saliva, or finger-prick blood. Sample collection, transportation and processing will occur within 24 to 48 hours using existing sample collection logistics infrastructure through a network of centralized laboratories.
Viral RNA detection
Flambeau Diagnostics, Madison, Wisconsin
A laboratory module that can be deployed on a mobile van to test asymptomatic people and detect low viral levels of SARS-CoV-2 in saliva samples, returning results in as little as one hour. The system can serve employers, schools and underserved populations. It uses new extraction technology to reliably and quickly purify and concentrate viral RNA.
Ubiquitome, Auckland, New Zealand
A mobile, battery-powered RT-PCR device that detects viral RNA with high accuracy within 40 minutes and reports results through its proprietary iPhone app. It offers high performance and could be much lower cost than laboratory RT-PCR tests. The device is intended for use in rural and metropolitan hospitals and mobile laboratories.
Visby Medical, San Jose, California
A palm-sized, single-use RT-PCR device that detects viral RNA with highly accurate results at the point of care in 30 minutes. The device was designed to be used by a person with minimal skills. This novel and versatile technology platform can also be adapted to provide simple and rapid testing for other diseases such as chlamydia, gonorrhea and influenza.
About Rapid Acceleration of Diagnostics (RADx)YE) initiative: The RADx initiative was launched on April 29, 2020 to accelerate innovation in the development, commercialization and deployment of technologies for COVID-19 testing. The initiative has four programs: RADx Tech, RADx Advanced Technology Platforms, RADx Underserved Populations and RADx Radical. Leverages existing NIH point-of-care technology research network. The RADx initiative partners 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 U.S. Food and Drug Administration. Learn more about the RADx initiative and its programs: https://www.nih.gov/radx.
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 https://www.nih.gov/radx.
About HHS, ASPR and BARDA: HHS works to improve and protect the health and well-being of all Americans by providing effective health and human services and advancing advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from the health security threats of the 21st century. Within ASPR, BARDA invests in innovation, advanced research and development, procurement and manufacturing of medical countermeasures: vaccines, medications, therapeutics, diagnostic tools and non-pharmaceutical products needed to combat threats to health security. To date, 55 BARDA-endorsed products have been approved, licensed, or cleared by the FDA. To learn more about BARDA’s portfolio of COVID-19 diagnostics, vaccines and treatments and how to partner with BARDA, visit medicalcountermeasures.gov. For more information about federal support for the COVID-19 response across the United States, visit coronavirus.gov.
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