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RAD-X Awards Six Phase 2 Contracts for COVID-19 Testing

NEW YORK – The National Institutes of Health in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) announced on Wednesday six Rapid Acceleration of Diagnostics (RADx) initiative contracts totaling $98.35 million.

The awards support clinical validation, manufacturing, and scale up of point-of-care and other novel test approaches that provide new modes of sample collection, processing, and return of results, the agency said in a statement.

The awards are part of the RADx Tech program, which is focused on rapidly advancing early testing technologies, while the RADx Advanced Technology Platforms (RADx-ATP) supports late-stage scale-up of projects. Combined, the two programs currently support a portfolio of 22 companies with a total of $476.4 million in manufacturing expansion contracts.

Speed, accuracy, cost, and accessibility are key considerations for RADx support, and the RADx initiative provides financial support and expertise to help companies reach milestones for US Food and Drug Administration authorization, scale up, and commercialization.

The six new Phase 2 RADx contracts were awarded to Quanterix (Billerica, Massachusetts), $18.2 million; Luminostics (Milpitas, California), $26.1 million; Flambeau Diagnostics (Madison, Wisconsin), $12.0 million; Ellume (Valencia, California), $30.0 million; Visby Medical (San Jose, California), $9.6 million; and Ubiquitome (Auckland, New Zealand), $2.5 million.

Innovations in the 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 NIH said.

The six additional technologies are expected to add as many as 500,000 tests per day to the US SARS-CoV-2 testing capacity by the end of 2020, and 1 million tests per day by early 2021, the agency said. 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, the agency said.

"Each of the technologies emerging from the RADx initiative will play a critical role in extending accessibility to testing in diverse settings," said NIH Director Francis Collins.

Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and lead for RADx Tech Bruce Tromberg said that the current round of awards supports five technologies that can be delivered to the point of care and one "powerful" laboratory test. "The technologies include an antigen test that provides results in 15 minutes, a viral RNA test deployed in mobile vans that can travel to COVID hotspots, and tests that require only saliva, nasal swabs or blood from a finger prick," Tromberg said.

BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services, provided the funding for the RADx Tech contracts from emergency supplemental appropriations to the Public Health and Social Services Emergency Fund. BARDA has supported 30 SARS-COV-2 diagnostic tests since March, half of which have achieved Emergency Use Authorization from the US Food and Drug Administration.

Ellume USA will now manufacture and scale up two test cartridges, each containing a single-use, digital fluorescent immunoassay antigen test that returns results in 15 minutes or less. One cartridge for nasal swabs can be read out on two platforms by healthcare professionals, at the point of care or in laboratory settings for higher throughput, while a second cartridge is being developed for home use with a self-administered nasal swab.

"We are working intensely to expand access to fast, accurate, and affordable testing for use in communities across the US, and this funding enables significant acceleration of our efforts," said Sean Parsons, founder and CEO of Ellume, in a separate statement. In addition to the two tests in this contract, the firm recently partnered with Qiagen for a high-throughput lab test.

Luminostics and Quanterix are also developing viral antigen detection technologies.

The Luminostics technology is a 30-minute test with a smartphone readout, and uses glow-in-the-dark nanomaterials to detect SARS-CoV-2 from shallow nasal swabs for point-of-care use, with home use applications expected in the future.

The Quanterix technology is a laboratory-based 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. The firm had announced Phase 1 funding in its second quarter earnings report.

For molecular diagnostic detection of the virus, Flambeau Diagnostics will scale up a lab module that can be deployed in a mobile van to screen asymptomatic individuals and detect low levels of SARS-CoV-2 in saliva samples, with results in as little as one hour using new extraction technology to purify and concentrate viral RNA.

The Ubiquitome technology, meanwhile, is a battery-operated, mobile RT-PCR device that detects viral RNA in 40 minutes and reports results with an iPhone app. The system is targeted for use in rural and metropolitan hospitals and mobile labs.

The Visby Medical technology is a palm-sized, single-use, RT-PCR device that detects viral RNA at the point of care in 30 minutes.