Six months into the COVID-19 pandemic, the question of why tests that detect the presence of the SARS-CoV-2 virus are not faster, better, and cheaper in this country still remains. Despite an incredibly complicated answer, the National Institutes of Health (NIH) has announced that they are going to help some companies work to develop their technologies, with the hope of getting over this roadblock. The program will give $248.7 million to seven biomedical diagnostic companies. The money is intended to support a range of new lab-based and point-of-care tests that, they hope, could significantly increase the number, type, and availability of tests by millions per week as early as September 2020.
The initiative is called NIH’s Rapid Acceleration of Diagnostics (RADx). “The RADx initiative has enabled some of the nation’s most creative biomedical device inventors to ramp up development of their testing technologies at unprecedented speed,” said NIH director Francis S. Collins, MD, PhD. “The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.”
The seven companies range in scope from small start-ups to large publicly-held organizations and their corresponding 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 FDA 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 the money have either received EUA from the FDA for their COVID-19 test or have applications in process.
NIH launched RADx on April 29, 2020, just days after receiving an emergency supplemental appropriation of $1.5 billion from Congress to support innovative technologies to make millions of rapid COVID-19 tests per week available to Americans by the fall. At that time, Collins issued a nationwide call to science and engineering’s most innovative minds. An overwhelming response ensued, culminating in more than 650 applications to date.
How were the seven companies chosen? NIH selected approximately 100 of the best concepts to enter an intense one-week “shark-tank” technology evaluation process. Thirty-one of these projects made the cut and moved to Phase 1, a rigorous four- to six-week period of initial technology validation. The seven tests announced here are the first to be chosen for scale up, manufacturing, and delivery to the marketplace through RADx. More than 20 companies remain actively engaged in meeting Phase 1 milestones and will be considered for Phase 2 awards in the coming weeks. In addition, dozens of promising concepts continue to move through the RADx “innovation funnel” and may be selected for Phase 1 and/or Phase 2 funding.
“This is an exciting milestone,” said Bruce J. Tromberg, PhD, 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, CA
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 to 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, CA
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, South San Francisco
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.