29 KiB
29 KiB
| 1 | Title | Project-Title | Project-Description | Budget | Link | Test-Setting | Type-of-Test | Status | Sample-Type | EUA-Date | EUA-Link |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 | Meridian Biosciences - Tech II | Rapid respiratory viral panel molecular assay | 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. | $2,500,000 | Lab | Nucleic acid, RT-PCR | Active | Nasal swab | |||
| 3 | Qorvo Biotechnologies, LLC - Tech II | POC Antigen Test using Biosensor for SARS-CoV-2 | 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. | $4,100,000 | POC | Antigen | Active | Nasal swab | |||
| 4 | Twist Bioscience - Tech I | An innovative OTC and POC lateral flow immunoassay that detects the Nucleocapsid (N) and Spike (S) proteins of the SARS-CoV-2 Coronavirus | 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. | $6,800,000 | POC | Antigen | Active | Nasal swab | |||
| 5 | AvantGen, Inc - Tech I | Highly Sensitive Rapid Test Kit for SARS-CoV-2 Antigen Detection That Does Not Require A Reader | 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. | $1,462,837 | POC | Antigen | Active | Nasal swab, Oral swab, Saliva | |||
| 6 | Tangen Biosciences, Inc. - Tech I | Scale up of Tangen Assay Production | 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. | $3,037,000 | POC | RT-LAMP | Active | Nasal swab | |||
| 7 | Anavasi Diagnostics - Tech I | Low-cost moderate-throughput Covid-19 test to support massive test scaleup at small clinics and community sites | 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. | $14,900,000 | POC | RT-LAMP | Active | Nasal swab | 02/08/2023 | https://www.fda.gov/media/165256/download | |
| 8 | Princeton BioMeditech - Tech II | Rapid, point of care, multiplex COVID-19 and Flu A&B antigen assay and Reader | 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. | $10,240,000 | POC | Antigen | Active | Nasal swab | 10/27/2021 | https://www.fda.gov/media/145694/download | |
| 9 | LumiraDx - Tech II | High sensitivity SARS-CoV-2 & Flu A/B Antigen Test on LumiraDx POC Platform | 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. | $5,493,000 | POC | Other | Active | Nasal swab | |||
| 10 | Luminostics, Inc. (dba Clip Health) - Tech II | Rapid, home-use, high-sensitivity, multiplexed Flu/Covid antigen self-test on a low-cost smartphone-connected standalone analyzer platform | 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. | $12,940,000 | POC | Antigen | Active | Nasal swab | |||
| 11 | Ellume USA, LLC - Tech II | Point of Care Flu-COVID Combination Diagnostic Tests | 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. | $3,500,000 | POC | Antigen | Active | Nasal swab | |||
| 12 | Becton, Dickinson and Company (BD) - Tech I | Scaling up Point-of-care SARS-CoV-2 Test Kit on BD Veritor | 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. | $457,000 | Home/Organization, POC | Antigen | Active | Nasal swab | 08/21/2021 | https://www.fda.gov/media/151771/download | |
| 13 | Uh-Oh Labs - Tech I | The Uh-Oh Labs SARS-CoV-2 Loop-de-Loop Assay for High-Throughput and Point-of-Care Use | 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. | $14,982,258 | POC | RT-LAMP | Active | Nasal swab, Oral swab, Saliva | 02/08/2022 | https://www.fda.gov/media/156099/download | |
| 14 | Quidel Corp. - Tech II | QuickVue OTC Flu+SARS Combo Kit & Savanna RVP4 | 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. | $717,800 | POC | Nucleic acid, Real-Time RT-PCR, antigen | Active | Nasal swab | |||
| 15 | Palogen - Tech II | Innovative Ultra-Fast Chip technology for Covid-19 RNA detection | A nanoelectronic biosensor that detects SARS-CoV-2 RNA in three minutes. The technology is initially intended for use at the point of care. | $8,000,000 | POC | Nucleic acid, biosensor | Active | Nasal swab, Oral swab, Saliva | |||
| 16 | Minute Molecular Diagnostics - Tech I | High-throughput, Fast-Turnaround, Field-Deployable COVID-19 Molecular Diagnostic System | 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. | $21,300,000 | POC | Nucleic acid, RT-PCR | Active | Nasal swab | 03/15/2022 | https://www.fda.gov/media/156976/download | |
| 17 | Qorvo Biotechnologies, LLC - Tech I | Biosensor for SARS-CoV-2 Antigen Test Application | 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. | $24,360,000 | POC | Antigen | Active | Nasal swab | 04/13/2021 | https://www.fda.gov/media/147575/download | |
| 18 | Mologic, Inc - Tech I | Rapid SARS-COV-2 Antigen detection test | 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. | $11,764,515 | Home/Organization, POC | Antigen | Active | Nasal swab | 02/22/2023 | https://www.fda.gov/media/165581/download | |
| 19 | Xtrava Inc, dba Xtrava Health - Tech I | Easy to deploy SARS-CoV-2 real-time testing and reporting platform with 10-100 times throughput improvement | 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. | $6,207,000 | POC | Antigen | Active | Nasal swab | 10/12/2021 | https://www.fda.gov/media/153093/download | |
| 20 | PathogenDx - Tech I | PathogenDx Microarray Assay for COVID-19 Testing: High Throughput Testing Capacity Scale-up | 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. | $7,577,154 | Lab | Other | Active | Nasal swab, Oral swab, Saliva | 04/20/2021 | https://www.fda.gov/media/147800/download | |
| 21 | GenBody Inc. - Tech I | U.S. regulatory approval and mass production of rapid antigen testing kit for detecting SARS-CoV-2 | 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. | $10,000,000 | Home/Organization, POC | Antigen | Active | Nasal swab | 02/17/2023 | https://www.fda.gov/media/165514/download | |
| 22 | Meridian Biosciences - Tech I | Rapid Acute Respiratory Viral Panel Assay | 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. | $5,500,000 | Lab | Nucleic acid, Real-Time RT-PCR | Active | Nasal swab | 11/09/2021 | https://www.fda.gov/media/154057/download | |
| 23 | Ellume USA, LLC - Tech I | An innovative point-of-care COVID 19 antigen test for the direct detection of the SARS-CoV-2 virus | 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. | $29,950,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-radx-initiative-advances-six-new-covid-19-testing-technologies | Home/Organization, Lab, POC | Antigen | Active | Nasal swab | 12/15/2020 | https://www.fda.gov/media/144457/download |
| 24 | Yukon Medical - Tech I | Versatile Swabs for SARS-CoV-2 Diagnostic Assay Platforms | 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. | $9,356,758 | https://www.nibib.nih.gov/news-events/newsroom/nih%E2%80%99s-radx-tech-program-inks-additional-contracts-covid-19-diagnostic-tests-and-supplies | Lab Products | Active | Nasal swab, Self Collect | |||
| 25 | Oasis Diagnostics Corp. - Tech I | Large Scale Up Manufacturing of Saliva Collection Technologies for COVID-19 Testing | 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. | $7,603,403 | https://www.nibib.nih.gov/news-events/newsroom/nih%E2%80%99s-radx-tech-program-inks-additional-contracts-covid-19-diagnostic-tests-and-supplies | Lab Products | Active | Oral swab, Saliva, Self Collect | |||
| 26 | Flambeau Diagnostics - Tech I | Massively parallel centralized and decentralized ultrafast COVID-19 infectiousness testing | 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. | $12,000,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-radx-initiative-advances-six-new-covid-19-testing-technologies | Lab | RT-LAMP | Active | Saliva | ||
| 27 | Luminostics, Inc. - Tech I | A smartphone-based at-home self-test for rapid SARS-CoV-2 antigen detection from respiratory samples | 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. | $26,120,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-radx-initiative-advances-six-new-covid-19-testing-technologies | POC | Antigen | Active | Nasal swab | 10/07/2020 | https://www.fda.gov/media/144253/download |
| 28 | Ceres Nanosciences, Inc - Tech I | Nanotrap manufacturing scale-up to meet rapidly expanding needs for direct SARS-CoV-2 detection in high-throughput settings | 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. | $14,774,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | Lab Products | Other | Active | Nasal swab, Oral swab, Saliva | ||
| 29 | Maxim Biomedical, Inc - Tech I | Maxim SARS-CoV-2 Antigen Rapid Test | 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. | $5,253,450 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | Home/Organization, POC | Antigen | Active | Nasal swab | 01/19/2022 | https://www.fda.gov/media/155632/download |
| 30 | Thermo Fisher Scientific (formerly Mesa Biotech, Inc.) - Tech I | Rapid Manufacturing Scale-up for Compact Point-of-Care EUA SARS-CoV-2 RT-PCR Test | 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. | $15,049,264 | /news-events/newsroom/nih-delivering-new-covid-19-testing-technologies-meet-us-demand | POC | Nucleic acid, RT-PCR | Active | Nasal swab | 01/07/2021 | https://www.fda.gov/media/136345/download |
| 31 | Quidel Corp. - Tech I | Manufacturing Capacity Scale-Up for Sofia SARS Antigen and Sofia Influenza A+B/SARS FIAs | 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. | $65,000,000 | /news-events/newsroom/nih-delivering-new-covid-19-testing-technologies-meet-us-demand | Home/Organization, POC | Antigen, lateral flow assay (LFA) | Active | Nasal swab, Other | 03/31/2021 | https://www.fda.gov/media/147247/download |
| 32 | Mirimus - Tech II | Saliva pool testing for high throughout detection and variant identification | 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. | $1,010,000 | Lab | Nucleic acid, RT-PCR | Completed | Saliva | |||
| 33 | University of California, Los Angeles - Tech I | SwabSeq: Simple pathogen detection using next-gen sequencing | 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. | $13,313,465 | Lab | Nucleic acid, next generation sequencing (NGS) | Completed | Nasal swab, Oral swab, Saliva, Sputum, Other | 10/06/2020 | https://www.fda.gov/media/142802/download | |
| 34 | Detect - Tech II | Expanded Manufacturing and Commercialization of Detect Covid-19 Test: Highly Scalable, Affordable, At-Home Rapid Molecular Test | 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. | $8,100,000 | POC | RT-LAMP | Completed | Nasal swab | 10/28/2021 | https://www.fda.gov/media/167181/download | |
| 35 | Salignostics Ltd - Tech I | Development of a Saliva-based SARS-CoV-2 Rapid Diagnostic Test for Home and Professional Use | 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. | $6,541,000 | Home/Organization, POC | Antigen | Completed | Saliva | |||
| 36 | ANP Technologies - Tech I | NIDS COVID-19 Multiplexed Oral Antigen Rapid Test Armed with Infection Predicting Capability | 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. | $19,727,817 | https://www.nibib.nih.gov/news-events/newsroom/nih%E2%80%99s-radx-tech-program-inks-additional-contracts-covid-19-diagnostic-tests-and-supplies | Home/Organization, POC | Antigen | Completed | Nasal swab | 11/17/2022 | https://www.fda.gov/media/163318/download |
| 37 | Visby Medical - Tech I | A Rapid, Accurate, Disposable Molecular Diagnostic to detect SARS-CoV-2 | 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. | $9,623,789 | https://www.nibib.nih.gov/news-events/newsroom/nih-radx-initiative-advances-six-new-covid-19-testing-technologies | POC | Nucleic acid, RT-PCR | Completed | Nasal swab | 02/08/2021 | https://www.fda.gov/media/163717/download |
| 38 | Ubiquitome - Tech I | SARS-CoV-2 lab test accuracy within reach of every American with Liberty16 mobile real time PCR | 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. | $2,460,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-radx-initiative-advances-six-new-covid-19-testing-technologies | POC | Nucleic acid, RT-PCR | Completed | Nasal swab | ||
| 39 | Quanterix - Tech I | Ultra-Sensitive Immunoassay Test for Quantitation of SARS-CoV-2 Antigen | 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. | $18,200,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-radx-initiative-advances-six-new-covid-19-testing-technologies | Lab | Antigen | Completed | Blood, Nasal swab, Saliva, Sputum | 01/05/2021 | https://www.fda.gov/media/144925/download |
| 40 | Sonic Healthcare USA - Tech I | Rapid Expansion of Existing Framework for Deploying Large-Scale COVID-19 RT-PCR Testing Platforms and Distributing Capacities | 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. | $20,799,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | Lab | Nucleic acid, RT-PCR | Completed | Nasal swab, Oral swab, Sputum, Other | ||
| 41 | PathGroup - Tech I | PathGroup SARS-CoV-2 High Throughput Laboratory Capacity Scale-Up | 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. | $20,750,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | Lab | Nucleic acid, RT-PCR | Completed | Nasal swab, Oral swab, Saliva, Other | 04/01/2021 | https://www.fda.gov/media/147651/download |
| 42 | Illumina, Inc - Tech I | Illumina MegaLab: A Massively Scaled Next Generation Sequencing Lab For COVID-19 Testing in the U.S. | 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. | $12,398,342 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | Lab | Nucleic acid, next generation sequencing (NGS) | Completed | Nasal swab, Oral swab, Other | 10/28/2020 | https://www.fda.gov/media/138778/download |
| 43 | Broad Institute - Tech I | Scaling the Broad Institute RT-PCR testing process to 100k+ tests/day | 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. | $14,584,482 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | Lab | Nucleic acid, RT-PCR | Completed | Nasal swab | 03/05/2021 | https://www.fda.gov/media/158208/download |
| 44 | Aegis Sciences - Tech I | Aegis Sciences Rapid Development of SARS-CoV-2 Test Capacity | 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. | $6,582,976 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | Lab | Nucleic acid, Real-Time RT-PCR | Completed | Nasal swab, Oral swab | ||
| 45 | MicroGEM International - Tech I | Accurate, Sensitive & Affordable POC and At Home Testing Device | 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. | $40,928,479 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | POC | Nucleic acid, RT-PCR | Completed | Saliva | 04/14/2022 | https://www.fda.gov/media/157751/download |
| 46 | MatMaCorp - Tech I | Deployment of a rapid, point of use technology for Covid-19 testing | 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. | $5,317,000 | https://www.nibib.nih.gov/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity | POC | Nucleic acid, RT-PCR | Completed | Nasal swab, Oral swab, Saliva | https://www.fda.gov/media/151349/download | |
| 47 | Talis Biomedical Corp. - Tech I | Talis-One/Talis HT: Highly Scalable SARS-CoV-2 RNA Detection in Minutes, from POC to Hundred-per-Hour Throughput | 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. | $25,400,000 | /news-events/newsroom/nih-delivering-new-covid-19-testing-technologies-meet-us-demand | POC | Nucleic acid; Reverse transcription loop-mediated isothermal amplification (RT-LAMP) | Completed | Nasal swab, Oral swab | https://www.fda.gov/media/161289/download | |
| 48 | Mammoth Biosciences - Tech I | Detection of SARS-CoV-2 with the CRISPR-based DETECTR platform | 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. | $23,081,269 | /news-events/newsroom/nih-delivering-new-covid-19-testing-technologies-meet-us-demand | Lab | Nucleic acid, CRISPR, Reverse transcription loop-mediated isothermal amplification (RT-LAMP) | Completed | Nasal swab | 01/21/2022 | https://www.fda.gov/media/155637/download |
| 49 | Fluidigm Corp., Inc. - Tech I | Advanta Dx SARS-CoV-2 RT-PCR Assay for Saliva | 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. | $34,016,056 | /news-events/newsroom/nih-delivering-new-covid-19-testing-technologies-meet-us-demand | Lab | Nucleic acid, RT-PCR | Completed | Nasal swab, Saliva | 02/26/2021 | https://www.fda.gov/media/141538/download |
| 50 | Helix OpCo, LLC - Tech I | Reproducible clinical test system for 1 million daily SARS-CoV-2 tests using amplicon sequencing | 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. | $33,421,500 | /news-events/newsroom/nih-delivering-new-covid-19-testing-technologies-meet-us-demand | Lab | Nucleic acid, next generation sequencing (NGS) | Completed | Nasal swab, Oral swab | 10/22/2020 | https://www.fda.gov/media/140422/download |
| 51 | Ginkgo Bioworks - Tech I | RADx-ATP Concentric: A High-Throughput Next Generation Sequencing-based Molecular Diagnostic for SARS-CoV-2 | 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. | $40,473,832 | /news-events/newsroom/nih-delivering-new-covid-19-testing-technologies-meet-us-demand | Lab | Nucleic acid, next generation sequencing (NGS) | Completed | Nasal swab, Oral swab, Saliva |