RADx℠ Tech and ATP Programs: Phase 2 Awards

Overview

The NIH Rapid Acceleration of Diagnostics (RADxSM) Initiative aims to accelerate the development and commercialization of diagnostic tests to detect the SARS-CoV-2 virus.  Two RADxSM programs within this Initiative—RADxSM Tech and RADxSM 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: 10/06/2020.

Visby Medical

Project Title:

A Rapid, Accurate, Disposable Molecular Diagnostic to detect SARS-CoV-2

Project Description:

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.

Estimated Budget:$9,623,789

Visby Medical

Sample Type(s):

Nasal swab

Type of Test:

Nucleic acid, RT-PCR

Test Location:

POC

Status:

Active

Ubiquitome

Project Title:

SARS-CoV-2 lab test accuracy within reach of every American with Liberty16 mobile real time PCR

Project Description:

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.

Estimated Budget:$2,460,000

Ubiquitome

Sample Type(s):

Nasal swab

Type of Test:

Nucleic acid, RT-PCR

Test Location:

POC

Status:

Active

Flambeau Diagnostics

Project Title:

Massively parallel centralized and decentralized ultrafast COVID-19 infectiousness testing

Project Description:

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.

Estimated Budget:$12,000,000

Flambeau Diagnostics

Sample Type(s):

Saliva

Type of Test:

RT-LAMP

Test Location:

POC

Status:

Active

Quanterix

Project Title:

Ultra-Sensitive Immunoassay Test for Quantitation of SARS-CoV-2 Antigen

Project Description:

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.

Estimated Budget:$18,200,000

Quanterix

Sample Type(s):

Blood, Nasal swab, Saliva, Sputum

Type of Test:

Antigen

Test Location:

Lab

Status:

Active

Luminostics, Inc.

Project Title:

A smartphone-based at-home self-test for rapid SARS-CoV-2 antigen detection from respiratory samples

Project Description:

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.

Estimated Budget:$26,120,000

Luminostics, Inc.

Sample Type(s):

Nasal swab

Type of Test:

Antigen

Test Location:

POC

Status:

Active

Ellume USA LLC

Project Title:

An innovative point-of-care COVID 19 antigen test for the direct detection of the SARS-CoV-2 virus

Project Description:

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.

Estimated Budget:$29,950,000

Ellume USA LLC

Sample Type(s):

Nasal swab

Type of Test:

Antigen

Test Location:

POC

Status:

Active

Sonic Healthcare USA

Project Title:

Rapid Expansion of Existing Framework for Deploying Large-Scale COVID-19 RT-PCR Testing Platforms and Distributing Capacities

Project Description:

Expanded scope and expedited timeline of a framework for large-scale COVID-19 RT-PCR testing platforms and distribution capacity. With a network of regional testing hubs, the company can simultaneously deploy multiple test platforms and methodologies. They will continue to add capacity to reach about 166,000 samples tested per day with new high-throughput technology.

Estimated Budget:$20,799,000

Sonic Healthcare USA

Sample Type(s):

Nasal swab, Oral swab, Sputum, Other

Type of Test:

Nucleic acid, RT-PCR

Test Location:

Lab

Status:

Active

PathGroup

Project Title:

PathGroup SARS-CoV-2 High Throughput Laboratory Capacity Scale-Up

Project Description:

Uses Roche 6800 and Hologic Panther instruments to currently process about 10,000 COVID-19 RNA tests a day. Has infrastructure in place in 20 states throughout the U.S. Southeast and Midwest. They have partnered with ThermoFisher, LGC and Illumina to add additional instrumentation and automation to increase the daily number of COVID-19 tests performed to 80,000 by December 2020.

Estimated Budget:$20,750,000

PathGroup

Sample Type(s):

Nasal swab, Oral swab, Saliva, Other

Type of Test:

Nucleic acid, RT-PCR

Test Location:

Lab

Status:

Active

Illumina Inc

Project Title:

Illumina MegaLab: A Massively Scaled Next Generation Sequencing Lab For COVID-19 Testing in the U.S.

Project Description:

Automated sample processing and next-generation sequencing technology for COVID-19 testing that will be scaled up. Its high-throughput capacity can be expanded to 48,000 tests per day. Upon receipt of samples at the laboratory, the company can process results for the Illumina COVIDSeq test within 24 hours.

Estimated Budget:$12,398,342

Illumina Inc

Sample Type(s):

Nasal swab, Oral swab, Other

Type of Test:

Nucleic acid, next generation sequencing (NGS)

Test Location:

Lab

Status:

Active

Ceres Nanosciences Inc

Project Title:

Nanotrap manufacturing scale-up to meet rapidly expanding needs for direct SARS-CoV-2 detection in high-throughput settings

Project Description:

A sample prep method using Nanotrap particles that extracts and concentrates viral material to reduce processing time and improve sensitivity. This method can be used on a variety of testing platforms, from point-of-care systems to high-throughput laboratory processes, to improve speed and performance by 2- to 10-fold.

Estimated Budget:$6,574,000

Ceres Nanosciences Inc

Sample Type(s):

Nasal swab, Oral swab, Saliva

Type of Test:

Other

Test Location:

Lab

Status:

Active

Broad Institute

Project Title:

Scaling the Broad Institute RT-PCR testing process to 100k+ tests/day

Project Description:

A high-throughput RT-PCR COVID-19 viral test using specimens from nasal swabs that will be scaled up. Its facility already performs tests for more than 530 regional hospitals, nursing homes, shelters, community health centers, senior living facilities and at state and city collection sites in vulnerable communities. The award is helping to increase from 25,000 to 100,000 tests per day.

Estimated Budget:$14,584,482

Broad Institute

Sample Type(s):

Nasal swab

Type of Test:

Nucleic acid, RT-PCR

Test Location:

Lab

Status:

Active

Aegis Sciences

Project Title:

Aegis Sciences Rapid Development of SARS-CoV-2 Test Capacity

Project Description:

A novel coronavirus nucleic acid detection kit and distribution system for high through-put testing that uses nasal and oral swab samples. Has recently quadrupled capacity to 15,000 samples per day and will soon reach 60,000 samples per day. After receipt of samples, these tests will return results in 24 hours or less on average. 

Estimated Budget:$6,582,976

Aegis Sciences

Sample Type(s):

Nasal swab, Oral swab

Type of Test:

Nucleic acid, Real-Time RT-PCR

Test Location:

Lab

Status:

Active

MicroGEM International

Project Title:

Accurate, Sensitive & Affordable POC and At Home Testing Device

Project Description:

A portable, point-of-care device that detects SARS-CoV-2 in saliva samples using RT-PCR in 15 minutes. The test uses a microfluidic cartridge with the potential for simultaneous detection of multiple pathogens such as influenza.

Estimated Budget:$40,928,479

MicroGEM International

Sample Type(s):

Nasal swab, Saliva, Sputum

Type of Test:

Nucleic acid, RT-PCR

Test Location:

POC

Status:

Active

Maxim Biomedical Inc

Project Title:

Maxim SARS-CoV-2 Antigen Rapid Test

Project Description:

A single-use, lateral-flow test strip immunoassay that can provide results in 15 minutes or less. With the improved workflow, the assay can be performed without an instrument for reading and does not require any specialized equipment.

Estimated Budget:$5,253,450

Maxim Biomedical Inc

Sample Type(s):

Nasal swab

Type of Test:

Antigen

Test Location:

POC

Status:

Active

MatMaCorp

Project Title:

Deployment of a rapid, point of use technology for Covid-19 testing

Project Description:

A portable mini-lab that can rapidly perform multiple RT-PCR assays in a single platform. This technology can be used with multiple sources of reagents and is targeted for community hospitals and clinics in underserved, rural populations.

Estimated Budget:$1,390,000

MatMaCorp

Sample Type(s):

Nasal swab, Oral swab, Saliva

Type of Test:

Nucleic acid, RT-PCR

Test Location:

POC

Status:

Active

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.

Estimated Budget:$18,536,704

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.

Estimated Budget:$25,400,000

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.

Estimated Budget:$71,000,000

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.

Estimated Budget:$23,081,269

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 Corporation, Inc.

Project Title:

Advanta Dx SARS-CoV-2 RT-PCR Assay for Saliva

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.

Estimated Budget:$36,834,000

Fluidigm Corporation, Inc.

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.

Estimated Budget:$33,421,500

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.

Estimated Budget:$40,473,832

Ginkgo Bioworks

Sample Type(s):

Nasal swab, Oral swab, Saliva

Type of Test:

Nucleic acid, next generation sequencing (NGS)

Test Location:

Lab

Status:

Active