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NIH RADx Initiative Advances Six New COVID-19 Testing Technologies

Credit: Ellume/Luminostics

The National Institutes of Health, working in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), announced on Oct. 6 a third round of contract awards for scale-up and manufacturing of new COVID-19 testing technologies.

The six new Rapid Acceleration of Diagnostics (RADx) initiative contracts total $98.35 million for point-of-care and other novel test approaches that provide new modes of sample collection, processing and return of results. Innovations in these new technologies include integration with smart devices, mobile-lab processing that can be deployed to COVID-19 hot spots, and test results available within minutes.

The following companies have achieved key RADx Tech milestones and will receive support for manufacturing and scale up:

Viral Antigen Detection

Ellume USA LLC, Valencia, California

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, Inc., Milpitas, California

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, Massachusetts

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, Wisconsin

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, 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, versatile technology platform can also be adapted to provide simple, rapid tests for other diseases such as chlamydia, gonorrhea, and influenza.

These awards are part of the RADx Tech program, launched in late April 2020, which is focused on rapidly advancing early testing technologies. RADx Tech and the RADx Advanced Technology Platforms (RADx-ATP) —the latter for late-stage scale-up projects— are now supporting a combined portfolio of 22 companies for a total of $476.4 million in manufacturing expansion contracts. These six additional technologies are expected to add as many as 500,000 tests per day to the U.S. capacity by the end of 2020 and 1 million tests per day by early 2021. Combined with previous contracts announced in July and September, RADx Tech and RADx-ATP contracts are expected to increase test capacity by 2.7 million tests per day by the end of 2020.

BARDA, part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provided the funding for these RADx Tech contracts from emergency supplemental appropriations to the Public Health and Social Services Emergency Fund.

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