RADx® Tech and ATP Programs: Phase 2 Awards

Becton, Dickinson and Company (BD) - Tech I

Project Title: Scaling up Point-of-care SARS-CoV-2 Test Kit on BD Veritor

Project Description:

Two separate product lines to detect SARS-CoV-2 in 15 minutes or less. One is a lateral flow immunoassay with a reader which delivers electronic results intended to be used in point-of-care settings. The second is an at-home lateral flow test that is digitally read by a smartphone. 

Estimated Budget: $457,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: Home/Organization, POC
Status: Active
EUA: 08/21/2021  FDA Letter

This company holds additional EUAs; please see the FDA website for more information.

Mologic, Inc - Tech I

Project Title: Rapid SARS-COV-2 Antigen detection test

Project Description:

A lateral flow immunoassay capable of detecting SARS-CoV-2 with visually read results in 20 minutes. The unique design integrates all the test components into one cartridge to enable easy use by the individual performing the test. The antigen test is intended to be used in point-of-care settings and at home.

Estimated Budget: $11,764,515

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: Home/Organization, POC
Status: Active
EUA: 02/22/2023  FDA Letter

GenBody Inc. - Tech I

Project Title: U.S. regulatory approval and mass production of rapid antigen testing kit for detecting SARS-CoV-2

Project Description:

A visually read, single lateral flow rapid test system capable of detecting the SARS-CoV-2 that can deliver results within 20 minutes. The test can be performed by a healthcare professional and an at-home test is in development for future use.

Estimated Budget: $10,000,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: Home/Organization, POC
Status: Active
EUA: 02/17/2023  FDA Letter

Ellume USA, LLC - Tech I

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 is for a home kit to use with a self-administered nasal swab. A second cartridge in development would be read out by healthcare professionals, either at the point of care or in laboratory settings for higher throughput.

Estimated Budget: $29,950,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: Home/Organization, Lab, POC
Status: Active
EUA: 12/15/2020  FDA Letter

ExemptThis company holds additional EUAs; please see the FDA website for more information.

Maxim Biomedical, Inc - Tech I

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

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: Home/Organization, POC
Status: Active
EUA: 01/19/2022  FDA Letter

EUA achieved with support of ITAP program

Quidel Corp. - Tech I

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

Project Description:

Quidel offers two separate product lines. The Sofia test kit, a lateral flow immunoassay, is used with Sofia and Sofia 2 Analyzers which give electronic results within 15 minutes. The QuickVue test uses a dipstick—a simple paper-like test strip that is dipped into a specimen tube—to detect SARS-CoV-2 antigens. Results are displayed in 10 minutes without a specialized electronic reader.  Both of these products have EUA.

Estimated Budget: $65,000,000

Sample Type: Nasal swab, Other
Type of Test: Antigen, lateral flow assay (LFA)
Test Setting: Home/Organization, POC
Status: Active
EUA: 03/31/2021  FDA Letter

This company holds additional EUAs; please see the FDA website for more information.

Detect - Tech II

Project Title: Expanded Manufacturing and Commercialization of Detect Covid-19 Test: Highly Scalable, Affordable, At-Home Rapid Molecular Test

Project Description:

A rapid, reverse transcriptase-loop mediated isothermal amplification (RT-LAMP) platform with mobile app-guided instructions to detect SARS-CoV-2 in about 60 minutes. The test is anticipated to have analytical performance nearly as high as laboratory polymerase chain reaction (PCR) tests, but in a compact, cost-effective package that is intended for point-of-care settings and home use. The technology may also be expanded to test for other respiratory pathogens like influenza A/B. 

Estimated Budget: $8,100,000

Sample Type: Nasal swab
Type of Test: RT-LAMP
Test Setting: POC
Status: Completed
EUA: 10/28/2021  FDA Letter

EUA Revoked 4/14/2023

ANP Technologies - Tech I

Project Title: NIDS COVID-19 Multiplexed Oral Antigen Rapid Test Armed with Infection Predicting Capability

Project Description:

A lateral flow immunoassay platform technology that detects SARS-CoV-2 antigens. The rapid test delivers results in 15 minutes and is being validated for potential at-home use.

Estimated Budget: $19,727,817

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: Home/Organization, POC
Status: Completed
EUA: 11/17/2022  FDA Letter

This company holds an EUA for POC test since 9/24/2021. Please see the FDA website for more information.

Qorvo Biotechnologies, LLC - Tech II

Project Title: POC Antigen Test using Biosensor for SARS-CoV-2

Project Description:

A SARS-CoV-2 and influenza A/B all-in-one antigen test that uses an acoustic biosensor for detection in 20 minutes. The test can be performed by a trained healthcare professional. It returns rapid results in point-of-care settings like a doctor’s office, nursing home, business or airport.

Estimated Budget: $4,100,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA:  FDA Letter

Twist Bioscience - Tech I

Project Title: An innovative OTC and POC lateral flow immunoassay that detects the Nucleocapsid (N) and Spike (S) proteins of the SARS-CoV-2 Coronavirus

Project Description:

A lateral flow immunoassay that detects SARS-CoV-2 with visual results in 10 minutes. The antigen test is intended to be available over the counter for use at home and in point-of-care settings, including clinics and doctors’ offices.

Estimated Budget: $6,800,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA:  FDA Letter

AvantGen, Inc - Tech I

Project Title: Highly Sensitive Rapid Test Kit for SARS-CoV-2 Antigen Detection That Does Not Require A Reader

Project Description:

A lateral flow immunoassay that detects SARS-CoV-2 with visually read results in 15 minutes. The antigen test is intended to be used in point-of-care settings and at home.

Estimated Budget: $1,462,837

Sample Type: Nasal swab, Oral swab, Saliva
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA:  FDA Letter

Tangen Biosciences, Inc. - Tech I

Project Title: Scale up of Tangen Assay Production

Project Description:

A portable, RT-LAMP platform that simultaneously detects SARS-CoV-2 and influenza A/B. The platform enables multiplexing of up to 35 targets. Results are displayed on the instrument screen in 30 minutes. The test is intended for use in urgent care clinics, nursing homes, and other point-of-care settings.

Estimated Budget: $3,037,000

Sample Type: Nasal swab
Type of Test: RT-LAMP
Test Setting: POC
Status: Active
EUA:  FDA Letter

Anavasi Diagnostics - Tech I

Project Title: Low-cost moderate-throughput Covid-19 test to support massive test scaleup at small clinics and community sites

Project Description:

A rapid, reverse transcription loop-mediated isothermal amplification (RT-LAMP) platform that detects SARS-CoV-2 in 25 minutes. In the future, the platform has the potential to simultaneously detect other respiratory pathogens like influenza or be used for variant identification. Initially, the platform will be used in point-of-care settings like urgent care and has the potential for at-home use.

Estimated Budget: $14,900,000

Sample Type: Nasal swab
Type of Test: RT-LAMP
Test Setting: POC
Status: Active
EUA: 02/08/2023  FDA Letter

Princeton BioMeditech - Tech II

Project Title: Rapid, point of care, multiplex COVID-19 and Flu A&B antigen assay and Reader

Project Description:

A lateral flow assay antigen test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B all-in-one test. The test delivers visibly read results in about 15 minutes. Currently, the test has EUA for use in point-of-care settings and moderate- and high-complexity labs. The test will be validated for use at home. 

Estimated Budget: $10,240,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA: 10/27/2021  FDA Letter

LumiraDx - Tech II

Project Title: High sensitivity SARS-CoV-2 & Flu A/B Antigen Test on LumiraDx POC Platform

Project Description:

A microfluidic immunofluorescence assay that can detect SARS-CoV-2 and influenza A/B expected to have sensitivity approaching laboratory PCR. Multiplexed assay results are provided in less than 15 minutes. The test is intended for use in point-of-care settings. 

Estimated Budget: $5,493,000

Sample Type: Nasal swab
Type of Test: Other
Test Setting: POC
Status: Active
EUA:  FDA Letter

Luminostics, Inc. (dba Clip Health) - Tech II

Project Title: Rapid, home-use, high-sensitivity, multiplexed Flu/Covid antigen self-test on a low-cost smartphone-connected standalone analyzer platform

Project Description:

A rapid, smartphone-connected, antigen immunoassay that uses glow-in-the-dark nanomaterials to detect and differentiate SARS-CoV-2 and influenza A/B.  A reusable reader delivers results in 15 minutes and the test is intended for use in point-of-care settings. 

Estimated Budget: $12,940,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA:  FDA Letter

Ellume USA, LLC - Tech II

Project Title: Point of Care Flu-COVID Combination Diagnostic Tests

Project Description:

A single-use, digital fluorescent immunoassay antigen test for SARS-CoV-2 and influenza A/B all-in-one platform. Results are returned in 15 minutes or less. The platform is paired with a mobile app for ease of use and is intended for use in point-of-care settings. 

Estimated Budget: $3,500,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA:  FDA Letter

Uh-Oh Labs - Tech I

Project Title: The Uh-Oh Labs SARS-CoV-2 Loop-de-Loop Assay for High-Throughput and Point-of-Care Use

Project Description:

A portable and reusable RT-LAMP device with single-use cartridges that detect SARS-CoV-2 in 30 minutes. The cartridge can be expanded to detect other respiratory pathogens like influenza A/B. The test is intended for use in point-of-care settings and is suitable for use at K-12 schools, universities, healthcare facilities and businesses. The test will also be validated for at-home use. 

Estimated Budget: $14,982,258

Sample Type: Nasal swab, Oral swab, Saliva
Type of Test: RT-LAMP
Test Setting: POC
Status: Active
EUA: 02/08/2022  FDA Letter

Quidel Corp. - Tech II

Project Title: QuickVue OTC Flu+SARS Combo Kit & Savanna RVP4

Project Description:

Two lateral flow assays combine in one package to detect SARS-CoV-2 and the influenza A/B viruses. Results are visible on the test strips in less than 15 minutes. A real-time PCR platform that simultaneously detects influenza A/B, respiratory syncytial virus and SARS-CoV-2 in less than 25 minutes. The platform has the capacity to expand to a multiplex of 12 assays at one time. The test is expected to be highly accurate and sensitive and will be intended for use in small hospitals and urgent care clinics. 

Estimated Budget: $717,800

Sample Type: Nasal swab
Type of Test: Nucleic acid, Real-Time RT-PCR, antigen
Test Setting: POC
Status: Active
EUA:  FDA Letter

Palogen - Tech II

Project Title: Innovative Ultra-Fast Chip technology for Covid-19 RNA detection

Project Description:

A nanoelectronic biosensor that detects SARS-CoV-2 RNA in three minutes. The technology is initially intended for use at the point of care. 

Estimated Budget: $8,000,000

Sample Type: Nasal swab, Oral swab, Saliva
Type of Test: Nucleic acid, biosensor
Test Setting: POC
Status: Active
EUA:  FDA Letter

Minute Molecular Diagnostics - Tech I

Project Title: High-throughput, Fast-Turnaround, Field-Deployable COVID-19 Molecular Diagnostic System

Project Description:

A RT-PCR device with single-use cartridges that detects SARS-CoV-2 in 15 minutes at the point-of-care. The test is suitable for K-12 schools, universities, healthcare facilities and businesses.

Estimated Budget: $21,300,000

Sample Type: Nasal swab
Type of Test: Nucleic acid, RT-PCR
Test Setting: POC
Status: Active
EUA: 03/15/2022  FDA Letter

Qorvo Biotechnologies, LLC - Tech I

Project Title: Biosensor for SARS-CoV-2 Antigen Test Application

Project Description:

A SARS-CoV-2 antigen test that uses an acoustic biosensor for detection in 20 minutes to achieve near PCR level accuracy. The test can be performed by a trained healthcare professional. It returns rapid results in point-of-care settings like a doctor’s office, nursing home, workplace or airport. In the future, the test may be combined with the flu test.  

Estimated Budget: $24,360,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA: 04/13/2021  FDA Letter

Xtrava Inc, dba Xtrava Health - Tech I

Project Title: Easy to deploy SARS-CoV-2 real-time testing and reporting platform with 10-100 times throughput improvement

Project Description:

A lateral flow immunoassay platform technology for antigen detection of SARS-CoV-2. In the presence of the virus a visible line develops in 15 minutes or less which can be observed by eye or, with greater sensitivity, using the accompanying portable digital reader and smartphone app. An over-the-counter use of the technology is being developed.

Estimated Budget: $6,207,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA: 10/12/2021  FDA Letter

Luminostics, Inc. - Tech I

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 in 30 minutes or less.  A version for home use will be developed.

Estimated Budget: $26,120,000

Sample Type: Nasal swab
Type of Test: Antigen
Test Setting: POC
Status: Active
EUA: 10/07/2020  FDA Letter

Thermo Fisher Scientific (formerly Mesa Biotech, Inc.) - Tech I

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. Results can be read from the removable cartridge in 30 minutes.

Estimated Budget: $15,049,264

Sample Type: Nasal swab
Type of Test: Nucleic acid, RT-PCR
Test Setting: POC
Status: Active
EUA: 01/07/2021  FDA Letter

Salignostics Ltd - Tech I

Project Title: Development of a Saliva-based SARS-CoV-2 Rapid Diagnostic Test for Home and Professional Use

Project Description:

A lateral flow immunoassay capable of detecting SARS-CoV-2 with visually read results in 15 minutes. The antigen test is intended to be used in point-of-care settings and at home.

Estimated Budget: $6,541,000

Sample Type: Saliva
Type of Test: Antigen
Test Setting: Home/Organization, POC
Status: Completed
EUA:  FDA Letter

Visby Medical - Tech I

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 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

Sample Type: Nasal swab
Type of Test: Nucleic acid, RT-PCR
Test Setting: POC
Status: Completed
EUA: 02/08/2021  FDA Letter

Revoked 12/02/2022

Ubiquitome - Tech I

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

Sample Type: Nasal swab
Type of Test: Nucleic acid, RT-PCR
Test Setting: POC
Status: Completed
EUA:  FDA Letter

MicroGEM International - Tech I

Project Title: Accurate, Sensitive & Affordable POC and At Home Testing Device

Project Description:

A portable device that detects SARS-CoV-2 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

Sample Type: Saliva
Type of Test: Nucleic acid, RT-PCR
Test Setting: POC
Status: Completed
EUA: 04/14/2022  FDA Letter

MatMaCorp - Tech I

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: $5,317,000

Sample Type: Nasal swab, Oral swab, Saliva
Type of Test: Nucleic acid, RT-PCR
Test Setting: POC
Status: Completed
EUA:  FDA Letter

Issued 12/17/20, revoked 8/3/21

Talis Biomedical Corp. - Tech I

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

Project Description:

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

Sample Type: Nasal swab, Oral swab
Type of Test: Nucleic acid; Reverse transcription loop-mediated isothermal amplification (RT-LAMP)
Test Setting: POC
Status: Completed
EUA:  FDA Letter

Issued 11/05/2021, Revoked 8/23/2022

Meridian Biosciences - Tech II

Project Title: Rapid respiratory viral panel molecular assay

Project Description:

A single-use, automated, microfluidic cartridge-based RT-PCR test for the detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV) in one test. Provides rapid results available in an hour or less. The test is intended for use by qualified laboratory personnel, especially in small hospitals and labs. The instrument is compatible with laboratory information management systems.

Estimated Budget: $2,500,000

Sample Type: Nasal swab
Type of Test: Nucleic acid, RT-PCR
Test Setting: Lab
Status: Active
EUA:  FDA Letter

PathogenDx - Tech I

Project Title: PathogenDx Microarray Assay for COVID-19 Testing: High Throughput Testing Capacity Scale-up

Project Description:

A low-cost, high-throughput test that can target multiple SARS-CoV-2 sites with high accuracy, while delivering results within five hours. The multi-target test may be highly effective in detecting SARS-CoV-2 variants. The test has the capability to pool up to six saliva samples for surveillance testing at schools and businesses. Currently, 96 samples can be run at a time.

Estimated Budget: $7,577,154

Sample Type: Nasal swab, Oral swab, Saliva
Type of Test: Other
Test Setting: Lab
Status: Active
EUA: 04/20/2021  FDA Letter

Meridian Biosciences - Tech I

Project Title: Rapid Acute Respiratory Viral Panel Assay

Project Description:

A single-use, automated, microfluidic cartridge-based RT-PCR test for the detection of SARS-CoV-2 with results available in about 45 minutes.  The test is intended for use by qualified laboratory personnel, and regulatory approval will be pursued for use in both high and moderate complexity labs.  In addition, a respiratory panel that includes SARS-CoV-2, Influenza A/B, and RSV in one test is in development.

Estimated Budget: $5,500,000

Sample Type: Nasal swab
Type of Test: Nucleic acid, Real-Time RT-PCR
Test Setting: Lab
Status: Active
EUA: 11/09/2021  FDA Letter

Flambeau Diagnostics - Tech I

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, 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

Sample Type: Saliva
Type of Test: RT-LAMP
Test Setting: Lab
Status: Active
EUA:  FDA Letter

Mirimus - Tech II

Project Title: Saliva pool testing for high throughout detection and variant identification

Project Description:

A quantitative reverse transcription polymerase chain reaction (RT-qPCR) pooled laboratory-based surveillance testing program that uses a saliva sample. The workflow is a high-throughput process with inclusion of up to 24 pooled samples. The COVID-19 testing program serves an estimated 600 schools and businesses. The proposed scale-up will double existing throughput capacity and expand geographic coverage to two additional locations.

Estimated Budget: $1,010,000

Sample Type: Saliva
Type of Test: Nucleic acid, RT-PCR
Test Setting: Lab
Status: Completed
EUA:  FDA Letter

University of California, Los Angeles - Tech I

Project Title: SwabSeq: Simple pathogen detection using next-gen sequencing

Project Description:

A next-generation sequencing technology for COVID-19 testing that will be scaled up to help increase surveillance of cases and variants in the United States. The technology allows samples to be pooled and processed in a larger batch to decrease cost and processing time while not compromising accuracy. The test is intended for use in a high-complexity lab. 

Estimated Budget: $13,313,465

Sample Type: Nasal swab, Oral swab, Saliva, Sputum, Other
Type of Test: Nucleic acid, next generation sequencing (NGS)
Test Setting: Lab
Status: Completed
EUA: 10/06/2020  FDA Letter

Quanterix - Tech I

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. 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

Sample Type: Blood, Nasal swab, Saliva, Sputum
Type of Test: Antigen
Test Setting: Lab
Status: Completed
EUA: 01/05/2021  FDA Letter

Sonic Healthcare USA - Tech I

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

Sample Type: Nasal swab, Oral swab, Sputum, Other
Type of Test: Nucleic acid, RT-PCR
Test Setting: Lab
Status: Completed
EUA:  FDA Letter

PathGroup - Tech I

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.

Estimated Budget: $20,750,000

Sample Type: Nasal swab, Oral swab, Saliva, Other
Type of Test: Nucleic acid, RT-PCR
Test Setting: Lab
Status: Completed
EUA: 04/01/2021  FDA Letter

Illumina, Inc - Tech I

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

Sample Type: Nasal swab, Oral swab, Other
Type of Test: Nucleic acid, next generation sequencing (NGS)
Test Setting: Lab
Status: Completed
EUA: 10/28/2020  FDA Letter

Broad Institute - Tech I

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 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

Sample Type: Nasal swab
Type of Test: Nucleic acid, RT-PCR
Test Setting: Lab
Status: Completed
EUA: 03/05/2021  FDA Letter

Issued 07/08/2020; revoked 05/05/2022

Aegis Sciences - Tech I

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 throughput testing with a goal of reaching 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

Sample Type: Nasal swab, Oral swab
Type of Test: Nucleic acid, Real-Time RT-PCR
Test Setting: Lab
Status: Completed
EUA:  FDA Letter

Mammoth Biosciences - Tech I

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

Sample Type: Nasal swab
Type of Test: Nucleic acid, CRISPR, Reverse transcription loop-mediated isothermal amplification (RT-LAMP)
Test Setting: Lab
Status: Completed
EUA: 01/21/2022  FDA Letter

Revoked 12/15/2022

Fluidigm Corp., Inc. - Tech I

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 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.

Estimated Budget: $34,016,056

Sample Type: Nasal swab, Saliva
Type of Test: Nucleic acid, RT-PCR
Test Setting: Lab
Status: Completed
EUA: 02/26/2021  FDA Letter

Helix OpCo, LLC - Tech I

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 100,000/day.

Estimated Budget: $33,421,500

Sample Type: Nasal swab, Oral swab
Type of Test: Nucleic acid, next generation sequencing (NGS)
Test Setting: Lab
Status: Completed
EUA: 10/22/2020  FDA Letter

This company holds additional EUAs; please see the FDA website for more information.

Ginkgo Bioworks - Tech I

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. 

Estimated Budget: $40,473,832

Sample Type: Nasal swab, Oral swab, Saliva
Type of Test: Nucleic acid, next generation sequencing (NGS)
Test Setting: Lab
Status: Completed
EUA:  FDA Letter

Yukon Medical - Tech I

Project Title: Versatile Swabs for SARS-CoV-2 Diagnostic Assay Platforms

Project Description:

Three swab types—for nasal, mid-turbinate, and nasopharyngeal samples—are designed for optimal sample collection and maximum release and can be used with multiple testing methods. The swabs also have a breakpoint that can be customized to the specific diagnostic test to reduce the risk of sample contamination. Nasopharyngeal swabs require administration by a healthcare professional, mid-turbinate swabbing requires clinical observation, and nasal swabs allow at-home, self-collection.

Estimated Budget: $9,356,758

Sample Type: Nasal swab, Self Collect
Type of Test: 
Test Setting: Lab Products
Status: Active
EUA:  FDA Letter

Exempt from EUA.

Oasis Diagnostics Corp. - Tech I

Project Title: Large Scale Up Manufacturing of Saliva Collection Technologies for COVID-19 Testing

Project Description:

Unique saliva and cheek swab collection kits used with multiple types of testing platforms, such as RT-PCR, antigen, and next-generation sequencing. The collection kits purify saliva specimens, mitigating various problems related to viscosity and impurities. The collection kit can be used for at-home, self-collection, or at the point-of-need, as samples remain stable at room temperature.

Estimated Budget: $7,603,403

Sample Type: Oral swab, Saliva, Self Collect
Type of Test: 
Test Setting: Lab Products
Status: Active
EUA:  FDA Letter

Ceres Nanosciences, Inc - Tech I

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

Project Description:

One contract scales up manufacturing of Nanotrap particles that extract and concentrate viral material from samples to reduce processing time and improve sensitivity. This method can be used on point-of-care or high-throughput laboratory platforms to improve speed and performance up to 10-fold. A second contract focuses on the development and implementation of a wastewater surveillance network in regions across the country.

Estimated Budget: $14,774,000

Sample Type: Nasal swab, Oral swab, Saliva
Type of Test: Other
Test Setting: Lab Products
Status: Active
EUA:  FDA Letter