RADx initiative issues contracts for new COVID-19 tests to fill gaps

Science Highlights
February 24, 2022
Patricia Wiley

Wastewater surveillance network continues to grow

The National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx®) Tech program has issued contracts to help meet the ongoing needs and challenges for COVID-19 diagnostic testing. Contracts totaling $29.7 million support the development, validation, scale-up, and manufacture of at-home, point-of-care and laboratory tests, some of which are designed to detect the SARS-CoV-2 and influenza viruses in one test.

With the addition of the new awards (details listed below), RADx Tech has now supported 50 projects since the initiative launched in April 2020. Currently, RADx Tech-supported projects have received 38 emergency use authorizations from the U.S. Food and Drug Administration and produced more than one billion at-home, point-of-care, and laboratory tests and test products for the detection of COVID-19.

As the pandemic continues to evolve, NIBIB is also supporting studies to assess the analytical performance of COVID-19 tests, including RADx Tech-supported tests and other COVID-19 tests available on the market, to determine if the performance of these tests are impacted by variants of concern, including omicron. In addition to analytical testing, clinical studies with patient samples containing live omicron virus to validate the performance of tests in a real-world setting are ongoing. Results of these studies are expected soon.

Update on RADx-supported wastewater surveillance tools

Wastewater in sewage treatment facilities can be tested to monitor the dynamics of certain diseases or even the presence of chemical pollutants in communities. The concept of sampling raw sewage is known as wastewater-based epidemiology and has been adopted for surveillance of SARS-CoV-2 infection dynamics. Monitoring wastewater can be an early warning system for public health officials that the prevalence of COVID-19 is increasing and helps to inform public health guidelines.

A RADx Tech-supported company, Ceres Nanoscience, has developed a nanoparticle that captures and concentrates SARS-CoV-2 virus particles from raw sewage. The nanoparticles significantly reduce the time and effort to process wastewater samples.

With additional support from RADx Tech, Ceres is establishing a wastewater-based network throughout the U.S. So far, nine Wastewater-based Epidemiology Centers of Excellence have been created. Each site has received materials and training to implement robust wastewater sampling procedures. The Centers of Excellence will expand capacity and extend services into underserved communities and provide critical information to public health officials.

Simultaneously, Ceres has been working closely with Emory University to develop a strategy for multi-level wastewater-based surveillance of COVID-19 throughout Atlanta with an emphasis on underserved communities. This wastewater surveillance network covers 49 communities, seven schools, and two correctional facilities. Last year, data from this network alerted public health officials which areas in Atlanta had high burdens of COVID-19.

The additional projects receiving support are:

Anavasi, San Diego

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.

Mirimus, Inc, New York

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.

Meridian Biosciences, Cincinnati

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.

Tangen Biosciences, Branford, Connecticut        

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.

AvantGen, Inc, San Diego

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.

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