Washington, DC–The National Institutes of Health is investing $248.7 million in new technologies to address challenges associated with COVID-19 testing (which detects SARS-CoV-2 coronavirus). NIH’s Rapid Acceleration of Diagnostics (RADx) initiative has awarded contracts to seven biomedical diagnostic companies to support a range of new lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by millions per week as early as September 2020. With national demand estimated to be millions more tests per day above current levels, these technologies are expected to make a significant contribution to expanding the nation’s testing capacity.
The seven technologies use different methods and formats and can be performed in a variety of settings to meet diverse needs. Four of the technologies introduce innovations in laboratory-based testing technologies including next generation sequencing, CRISPR and integrated microfluidic chips that could dramatically increase testing capacity and throughput while reducing the time to receive test results. Three technologies use platforms to provide nucleic acid and viral antigen tests that can give rapid results at the point of care, such as offices, manufacturing facilities, childcare centers, nursing homes and schools. Additionally, some of the tests offer more convenient sampling, such as saliva testing. The companies range in scope from small start-ups to large publicly held organizations. The U.S. Food and Drug Administration has been working with NIH and RADx external advisors to provide general advice on test validation and is prioritizing the review of emergency use authorization (EUA) for tests supported by RADx. The companies awarded today have either received EUA from the FDA for their COVID-19 test or have applications in process.
he following companies have achieved key RADx milestones and will receive support for manufacturing and scale up.
Mesa Biotech, San Diego
The company’s Accula SARS-CoV-2 test employs a hand-held RT-PCR device and a compact, single-use cartridge that detects viral RNA at the point of care. Results can be read from the removable cartridge in 30 minutes.
Quidel, San Diego
The Quidel Sofia SARS Antigen FIA test kit, a lateral flow immunoassay, is used with Sofia and Sofia 2 Analyzers in point-of-care settings, such as a doctor’s office or pharmacy. There are currently thousands of Quidel analyzers in place across the United States and HHS has identified this technology for use in nursing homes. The analyzers give electronic results within 15 minutes.
Talis Biomedical, Menlo Park, California
The Talis One COVID-19 point of care test is 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.
Ginkgo Bioworks, Boston
Ginkgo Bioworks is scaling up using significant automation for handling samples and high-throughput, next-generation sequencing technologies to process tens of thousands of individual tests at once. Working with universities, schools, public or private companies and local communities, Ginkgo Bioworks will provide end-to-end sample collection and report results within 24-48 hours from sample receipt. The company is expected scale up to 50,000 tests per day in September 2020 and 100,000 per day by the end of the year.
Helix OpCo, San Mateo, California
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 that can be processed at once and within 24-48 hours, in very high volumes, using a combination of sophisticated automation processes and the use of next generation sequencing technologies. Helix is expected to process up to 50,000 samples a day by end of September 2020 and 100,000 samples per day at the end of the year.
Fluidigm, South San Francisco, California
Each BioMark HD microfluidics platform has the capacity to process thousands of SARS-CoV-2 PCR tests per day with a primary focus on saliva samples. With many existing Fluidigm instruments in clinical and research labs throughout the United States, scale up and deployment of their advanced integrated fluidic chips can provide tens to hundreds of thousands of new tests per day in fall 2020.
Mammoth Biosciences, Inc., South San Francisco, California
The Mammoth Biosciences SARS-CoV-2 DETECTR 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.