The National Institutes of Health (NIH) announced three new contracts and one new award to an existing contract for scale-up and manufacturing of novel covid-19 testing technologies. The four Rapid Acceleration of Diagnostics (RADx) initiative contracts total $65.6 million for home and point-of-care testing and the development and implementation of wastewater-based surveillance systems.

NIH launched the RADx initiative to speed innovation for covid-19 testing. There are four RADx programs: RADx Advanced Technologies Platforms (RADx ATP), RADx Tech, RADx Underserved Populations (RADx-UP), and RADx Radical (RADx-rad).

These awards are part of the RADx Tech program, which has aimed to speed innovation at an unprecedented pace to develop, commercialize, and implement covid-19 diagnostics. Testing has been a key mitigation strategy to help reduce SARS-CoV-2 transmission and will help the world return to normal activities. Many states eased restrictions after seeing a steady decline in covid-19 cases and an increase in covid-19 vaccinations. As businesses opened, however, states saw growing numbers of covid-19 cases again and increases in the prevalence of covid-19 variants.

“Vaccinations are a huge plus, but not everyone is vaccinated yet and covid-19 cases are increasing in many areas, so continued testing is critical,” says Bruce J. Tromberg, PhD, director of the National Institute for Biomedical Imaging and Bioengineering (NIBIB) and lead of RADx Tech. “This round of projects will help provide more options for testing and surveillance at businesses, schools, airports, and households as we re-open. Wastewater surveillance could prove to be another invaluable checkpoint in stopping the spread of the virus and its many variants.”

This announcement includes additional support for Ceres Nanosciences and builds on the company’s previous award made in September 2020 to manufacture Nanotrap particles that extract and concentrate the virus for more rapid and accurate testing in laboratory and point-of-care tests. Now the particles are being used to capture, extract, and concentrate virus directly from raw sewage before detection by RT-PCR. The particles are 20 times faster than other gold standard filtration methods. New methods to continue monitoring SARS-CoV-2 transmission in the population will help public health officials make informed decisions. One way to measure transmission in communities is to monitor and test wastewater. Wastewater surveillance can provide an early indicator of a resurgence in covid-19 cases, allowing targeted adjustments to public health policies to help affected communities. It can help stem cases before hospitals and healthcare systems get overwhelmed.  Many other countries are already using wastewater epidemiology for surveillance of covid-19.

Ceres will work with Emory University to build and implement a wastewater-based covid-19 surveillance framework in metro Atlanta. The framework will focus on underserved and vulnerable populations. By Fall 2021, Ceres will expand its wastewater surveillance method to 15 community sites throughout the country.

RADx is also continuing the emphasis on expanding rapid, accessible tests for home and the point of care, such as businesses, doctors’ offices, and clinics. Three additional contracts were awarded to expand the arsenal of tests available to open the country fully and safely.

The following companies have achieved key RADx Tech milestones and will receive support for manufacturing and scale-up:

Point-of-Care and Home Tests:

Mologic, New Gloucester, Maine

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 nasal swab antigen test is intended to be used in point-of-care settings and at home.

Qorvo Biotechnologies, Plymouth, Minn

A SARS-CoV-2 antigen test that uses an acoustic biosensor for detection in 20 minutes to achieve near- PCR-level accuracy. The test uses nasal swabs and 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.  

Minute Molecular Diagnostics, Evanston, Ill

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

Wastewater Surveillance:

Ceres Nanosciences, Manassas, Va

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. The particles can be used to extract the virus from many types of samples including nasal, saliva, blood, and wastewater.

Featured image: Among the new technologies being supported by RADx Tech to scale up manufacturing of covid-19 tests is a sample prep method using Nanotrap particles that extracts and concentrates viral material to reduce processing time and improve sensitivity. (Courtesy: Ceres Nanosciences)