The NIH Rapid Acceleration of Diagnostics (RADx) initiative announced that it has issued contract awards totaling $77.7 million to develop and manufacture 12 new rapid diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. The home and point-of-care testing platforms target the need for high-performance, low-cost home tests and point-of-care tests that can potentially detect multiple respiratory infections.
These projects are part of the RADx Tech program, which involves an intensive concept viability “shark-tank”-like assessment conducted by a panel of technical, regulatory and business experts. The awards support the development, validation, scale-up and manufacturing with the goal of bringing needed tests to the market as early as this year.
“These technologies represent important innovations to address the need for ready access to rapid, low-costs tests everywhere in the country, including in every home,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and lead for RADx Tech. “The potential to test simultaneously for multiple types of infection at the point-of-care, is a new frontier that we hope to advance and could be a major step toward transforming U.S. healthcare.”
The new awards are in addition to 33 that NIH previously disbursed through its technology development program. The RADx Tech program has resulted in 32 U.S. Food and Drug Administration emergency use authorizations (EUAs), including supporting the first home test EUA. Companies supported by the RADx program that achieved an EUA have contributed over 840 million tests to the U.S. market since fall of 2020.
The new tests receiving support for development, validation, and manufacturing and scale-up are:
Viral RNA detection-
- Detect, Guilford, Connecticut- A rapid, reverse transcriptase-loop mediated isothermal amplification (RT-LAMP) platform with mobile app-guided instructions to detect SARS-CoV-2 in about 60 minutes. The test is anticipated to have analytical performance nearly as high as laboratory polymerase chain reaction (PCR) tests, but in a compact, cost-effective package that is intended for point-of-care settings and home use. The technology may also be expanded to test for other respiratory pathogens like influenza A/B.
- Palogen, Palo Alto, California- A nanoelectronic biosensor that detects SARS-CoV-2 RNA in three minutes. The technology is initially intended for use at the point of care.
- Quidel, San Diego- A real-time PCR platform that simultaneously detects influenza A/B, respiratory syncytial virus and SARS-CoV-2 in less than 25 minutes. The platform has the capacity to expand to a multiplex of 12 assays at one time. The test is expected to be highly accurate and sensitive and will be intended for use in point-of-care settings like small hospitals and urgent care clinics.
- Uh-Oh Labs, Santa Clara, California- A portable and reusable RT-LAMP device with single-use cartridges that detect SARS-CoV-2 in 30 minutes. The cartridge can be expanded to detect other respiratory pathogens like influenza A/B. The test is intended for use in point-of-care settings and is suitable for use at K-12 schools, universities, healthcare facilities and businesses. The test will also be validated for at-home use.
- University of California, Los Angeles- A next-generation sequencing technology for COVID-19 testing that will be scaled up to help increase surveillance of cases and variants in the United States. The technology allows samples to be pooled and processed in a larger batch to decrease cost and processing time while not compromising accuracy. The test is intended for use in a high-complexity lab.
Viral antigen detection-
- Becton, Dickinson and Company (BD), Franklin Lakes, New Jersey- Two separate product lines to detect SARS-CoV-2 in 15 minutes or less. One is a lateral flow immunoassay with a reader which delivers electronic results intended to be used in point-of-care settings. The second is an at-home lateral flow test that is digitally read by a smartphone.
- Ellume USA LLC, Frederick, Maryland- A single-use, digital fluorescent immunoassay antigen test for SARS-CoV-2 and influenza A/B all-in-one platform. Results are returned in 15 minutes or less. The platform is paired with a mobile app for ease of use and is intended for use in point-of-care settings.
- Luminostics, Inc. (dba Clip Health), Milpitas, California- A rapid, smartphone-connected, antigen immunoassay that uses glow-in-the-dark nanomaterials to detect and differentiate SARS-CoV-2 and influenza A/B. A reusable reader delivers results in 15 minutes and the test is intended for use in point-of-care settings.
- LumiraDx, Waltham, Massachusetts- A microfluidic immunofluorescence assay that can detect SARS-CoV-2 and influenza A/B expected to have sensitivity approaching laboratory PCR. Multiplexed assay results are provided in less than 15 minutes. The test is intended for use in point-of-care settings.
- Princeton BioMeditech, Monmouth Junction, New Jersey- A lateral flow assay antigen test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B all-in-one test. The test delivers visibly read results in about 15 minutes. Currently, the test has EUA for use in point-of-care settings and moderate- and high-complexity labs. The test will be validated for use at home.
- Quidel, San Diego -Two lateral flow assays combine in one package to detect SARS-CoV-2 and the influenza A/B viruses. Results are visible on the test strips in less than 15 minutes. The combination test is being developed for use in point-of-care settings.