RADx Tech/ATP Phase 2 Awards

Overview

The NIH Rapid Acceleration of Diagnostics (RADx) Initiative aims to accelerate the development and commercialization of diagnostic tests to detect the SARS-CoV-2 virus.  Two RADx programs within this Initiative—RADx Tech and RADx ATP (Advanced Technology Platforms) —are supporting late stage development of innovative point-of-care and home-based tests, as well as improve clinical laboratory tests that will increase the capacity of testing in the U.S..

Data Updated: 8/3/2020.

Mesa Biotech, Inc.

Project Title:

Rapid Manufacturing Scale-up for Compact Point-of-Care EUA SARS-CoV-2 RT-PCR Test

Project Description:

This test employs a hand-held RT-PCR device and a compact, single-use cartridge that detects viral RNA at the point of care. Results can be read from the removable cartridge in 30 minutes.

Budget:$18,536,704

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Mesa Biotech, Inc.

Sample Type(s):

Nasal swab

Type of Test:

Nucleic acid, RT-PCR

Test Location:

POC

Status:

Active

Talis Biomedical Corp.

Project Title:

Talis-One/Talis HT: Highly Scalable SARS-CoV-2 RNA Detection in Minutes, from POC to Hundred-per-Hour Throughput

Project Description:

This point of care test is a multiplexed cartridge used with the compact Talis One instrument. The test detects SARS-CoV-2 through isothermal amplification of viral RNA and an optical detection system, returning a result in under 30 minutes.

Budget:$25,400,000

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Talis Biomedical Corp.

Sample Type(s):

Nasal swab, Oral swab

Type of Test:

Nucleic acid; Reverse transcription loop-mediated isothermal amplification (RT-LAMP)

Test Location:

POC

Status:

Active

Quidel Corp.

Project Title:

Manufacturing Capacity Scale-Up for Sofia SARS Antigen and Sofia Influenza A+B/SARS FIAs

Project Description:

This test kit, a lateral flow immunoassay, is used with Sofia and Sofia 2 Analyzers in point of care settings, such as a doctor’s office or pharmacy. There are currently thousands of Quidel analyzers in place across the U.S. and HHS has identified this technology for nursing homes. The Analyzers give electronic results within 15 minutes.

Budget:$71,000,000

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Quidel Corp.

Sample Type(s):

Nasal swab, Other

Type of Test:

Antigen, lateral flow assay (LFA)

Test Location:

POC

Status:

Active

Mammoth Biosciences

Project Title:

Detection of SARS-CoV-2 with the CRISPR-based DETECTR platform

Project Description:

This assay uses CRISPR technology, which provides a simpler workflow and significantly faster turnaround time compared to conventional laboratory PCR tests. This high-throughput solution can result in a multi-fold increase in testing capacity in commercial laboratories.

Budget:$23,081,269

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Mammoth Biosciences

Sample Type(s):

Nasal swab

Type of Test:

Nucleic acid, CRISPR, Reverse transcription loop-mediated isothermal amplification (RT-LAMP)

Test Location:

Lab

Status:

Active

Fluidigm Corp.

Project Title:

Scaling to Massive Throughput: 4.5 Million SARS-CoV-2 Tests per Day

Project Description:

Each BioMark HD microfluidics platform has the capacity to process thousands of SARS-CoV-2 PCR tests per day with a primary focus on saliva samples. With many existing Fluidigm instruments in clinical and research labs throughout the U.S., scale up and deployment of their advanced integrated fluidic chips can provide tens to hundreds of thousands of new tests per day in fall 2020.

Budget:$36,834,000

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Fluidigm Corp.

Sample Type(s):

Nasal swab, Saliva

Type of Test:

Nucleic acid, RT-PCR

Test Location:

Lab

Status:

Active

Helix OpCo, LLC

Project Title:

Reproducible clinical test system for 1 million daily SARS-CoV-2 tests using amplicon sequencing

Project Description:

Helix will ship standardized kits in bulk for the collection of nasal swabs to public health departments, health care systems, employers and other customers to collect tens of thousands of samples and processed within 24-48 hours using sophisticated automation processes and next generation sequencing technologies. Expected to process up to 50,000 samples/day by Sept. 2020 and 100,000/day by year’s end.

Budget:$33,421,500

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Helix OpCo, LLC

Sample Type(s):

Nasal swab, Oral swab

Type of Test:

Nucleic acid, next generation sequencing (NGS)

Test Location:

Lab

Status:

Active

Ginkgo Bioworks

Project Title:

RADx-ATP Concentric: A High-Throughput Next Generation Sequencing-based Molecular Diagnostic for SARS-CoV-2

Project Description:

Ginkgo is scaling up by using significant automation and next-generation sequencing technologies to process tens of thousands of tests at once. Working with universities, schools, public or private companies, and local communities, they will provide end-to-end sample collection and report results within 24-48 hours. Expected to scale up to 50,000 tests/day in Sept. 2020 and 100,000/day by year’s end.

Budget:$40,473,832

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Ginkgo Bioworks

Sample Type(s):

Nasal swab, Oral swab, Saliva

Type of Test:

Nucleic acid, next generation sequencing (NGS)

Test Location:

Lab

Status:

Active