The National Institutes of Health (NIH) today announced three new contracts and one new award of an existing contract for the scale-up and manufacturing of new COVID-19 testing technologies. the four Rapid Acceleration of Diagnostics (RADxYE) initiative The contracts total $65.6 million for home and point-of-care testing and the development and implementation of wastewater-based surveillance systems.
These awards are part of the RADx Tech program, which aims to accelerate innovation at an unprecedented pace to develop, commercialize and deploy COVID-19 diagnostics. Testing has been a key mitigation strategy to help reduce the transmission of SARS-CoV-2 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. However, as businesses opened, states again saw rising numbers of COVID-19 cases and increases in the prevalence of COVID-19 variants.
“Vaccines are a big 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, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and leader of RADx Tech. “This round of projects will help provide more options for testing and surveillance in businesses, schools, airports, and homes as we reopen. “Wastewater could prove to be another invaluable checkpoint in stopping the spread of the virus and its many variants.”
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 of COVID-19 cases, allowing targeted adjustments to public health policies to help affected communities. It can help stop cases before hospitals and health systems are overwhelmed. Many other countries are already using wastewater epidemiology for COVID-19 surveillance.
This announcement includes additional support for Ceres Nanosciences and is based on its previous award conducted in September 2020 to manufacture Nanotrap particles that extract and concentrate the virus for faster and more accurate testing in the laboratory and at the point of care. The particles are now being used to capture, extract and concentrate the virus directly from wastewater before detection by RT-PCR. Particles are twenty times faster than other standard filtration methods.
Ceres will work with Emory University to build and implement a wastewater-based COVID-19 surveillance framework in the greater Atlanta area. The framework will focus on vulnerable and underserved populations. By fall 2021, Ceres will expand its wastewater monitoring approach to 15 community sites nationwide.
RADx also continues to emphasize expanding rapid, accessible testing to the home and point-of-care, such as businesses, doctors’ offices and clinics. Three additional contracts were awarded to expand the arsenal of tests available to fully and safely open the country.
The following companies have achieved key RADx Tech milestones and will receive manufacturing and scale-up support:
Point-of-care and home testing
Mologic Inc, New Gloucester, ME
A lateral flow immunoassay capable of detecting SARS-CoV-2 with results read visually in 20 minutes. The unique design integrates all test components into a single cartridge to allow for easy use by the individual performing the test. The nasal swab antigen test is designed for use in point-of-care and at-home settings.
Qorvo Biotechnologies LLC., Plymouth, Minnesota
A SARS-CoV-2 antigen test that uses an acoustic biosensor for detection within 20 minutes and achieves accuracy close to PCR level. The test uses nasal swabs and can be performed by a trained healthcare professional. Delivers fast results in point-of-care settings such as 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, IL
An RT-PCR device with single-use cartridges that detects SARS-CoV-2 in 15 minutes at the point of care. The test uses nasal swabs and is suitable for schools, universities, healthcare facilities and businesses in kindergarten through 12th grade.
Wastewater monitoring
Ceres Nanoscience Inc, Manassas, Virginia
A sample preparation method using Nanotrap particles that extract and concentrate viral material to reduce processing time and improve sensitivity. This method can be used in a variety of test platforms, from point-of-care systems to high-throughput laboratory processes, to improve speed and performance by 2 to 10 times. The particles can be used to extract the virus from many types of samples, including nasal, saliva, blood and wastewater.
