Ellume’s rapid COVID-19 diagnostic (left) and Luminostics’ CLIP rapid COVID antigen test (right) are among potentially innovative testing tech receiving NIH support. [Image courtesy of NIH]
NIH awarded the contracts in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) as part of the Rapid Acceleration of Diagnostics (RADx) initiative. They cover innovations including integration with smart devices, mobile-lab processing that can be deployed to COVID-19 hot spots, and test results available within minutes.
“Since launching in April, the NIH RADx initiative has moved swiftly to facilitate critical expansion of early and late-stage testing technologies as well as research to remove barriers to testing for underserved and vulnerable populations,” NIH Director Dr. Francis S. Collins said in a news release. “Each of the technologies emerging from the RADx initiative will play a critical role in extending accessibility to testing in diverse settings.”
The contracts involve six companies that have achieved key RADx Tech milestones and will receive support for manufacturing and scale-up. The companies include:
Viral antigen detection
Ellume USA (Valencia, Calif.) – $30 million
“Two unique test cartridges contain a single-use, digital fluorescent immunoassay antigen test that returns accurate results in 15 minutes or less. One cartridge testing nasal swabs can be read out on two platforms by healthcare professionals, 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 (Milpitas, Calif.)
“A rapid, smartphone-readout, 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 later for home use.”
Quanterix (Billerica, Mass.) – $18.2 million
“A laboratory antigen test with ultra-sensitive single-molecule immunoassay technology to enable detection from a variety of sample types including nasopharyngeal, saliva or self-acquired blood from a finger prick. Sample collection, transport, and processing will occur within 24–48 hours using existing sample collection logistics infrastructure through a network of centralized labs.”
Viral RNA detection
Flambeau Diagnostics (Madison, Wis.)
“A lab module that can be deployed in a mobile van to screen asymptomatic individuals to detect SARS-CoV-2 at low viral levels 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 purify and concentrate viral RNA reliably and quickly.”
Ubiquitome (Auckland, New Zealand)
“A battery-operated, mobile RT-PCR device that detects viral RNA with high accuracy in 40 minutes and reports results via its proprietary iPhone app. It offers high throughput and could be much lower cost than lab-based RT-PCR tests. The device is targeted for use in rural and metropolitan hospitals and mobile labs.”
Visby Medical (San Jose, Calif.)
“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, versatile technology platform can also be adapted to provide simple, rapid tests for other diseases such as chlamydia, gonorrhea and influenza.”
