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.
“This is an exciting milestone,” said Bruce J. Tromberg, Ph.D., director of NIBIB and leader of RADx Tech, one of four components of the NIH RADx initiative. “It will increase U.S. testing capacity exponentially over the next few months. These and other technologies emerging from our RADx pipeline will guide patient care and inform public health measures to stop the spread of the virus and leave us better equipped to address future pathogens and other diseases.”
The 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, San Francisco
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.