This article has been updated to include additional information about the size of Ginkgo Bioworks' award from the NIH.
NEW YORK – The National Institutes of Health said on Friday that it is awarding a total of $248.7 million in contracts to seven biomedical diagnostic companies under its Rapid Acceleration of Diagnostics (RADx) initiative, to support a range of new lab-based and point-of-care tests for the detection of SARS-CoV-2, the virus causing the COVID-19 pandemic.
The goal of the program is to significantly increase the number, type, and availability of tests by millions per week by September, the NIH said. The seven technologies use different methods, and can be performed in a variety of settings.
Four of the companies use technologies such as next-generation sequencing, CRISPR, and integrated microfluidic chips that could significantly increase testing capacity and throughput, while also reducing turnaround time for results, the agency said. The other three companies use platforms to provide nucleic acid and viral antigen tests that can give rapid results at the point of care. Further, some of the tests operate on more convenient sample types, such as saliva.
The NIH launched RADx on April 29, after receiving an emergency supplemental appropriation of $1.5 billion from Congress to support the development of technologies that could make millions of rapid COVID-19 tests per week available by the fall. More than 650 applications to date have been submitted for participation in the program, the NIH said.
Hundreds of experts from government, academia, and industry — including the National Institute of Biomedical Imaging and Bioengineering's (NIBIB) Point-of-Care Technology Research Network (POCTRN) — are helping to evaluate applications. The NIH selected approximately 100 of the best concepts to enter a one-week technology evaluation process. Thirty-one of these projects moved to what the agency called Phase 1, a four- to six-week period of initial technology validation.
The seven tests to receive this tranche of funding were the first to be chosen for scale up, manufacturing, and delivery to the marketplace, but more than 20 companies are still actively engaged in meeting Phase 1 milestones and will be considered for Phase 2 awards in the coming weeks, the NIH said. Additionally, dozens of promising concepts are still being evaluated and may be selected for Phase 1 or Phase 2 funding at some point in the future.
The US Food and Drug Administration has also been working with the NIH and RADx external advisors to provide general advice on test validations, and is prioritizing the review of Emergency Use Authorization for tests supported by RADx, the NIH added.
"This is an exciting milestone," NBIB Director and RADx Tech Leader Bruce Tromberg said in a statement. "It will increase US 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."
Point-of-care tests
The three point-of-care tests receiving funding from the NIH include Quidel's Sofia SARS Antigen FIA test kit, Talis Biomedical's Talis One COVID-19 point-of-care test, and Mesa Biotech's Accula SARS-CoV-2.
The Quidel Sofia SARS Antigen FIA test kit is a lateral flow immunoassay. It's meant to be used with the company's Sofia and Sofia 2 Analyzers in settings such as a doctor's office or pharmacy. The analyzers return electronic results within 15 minutes.
The FDA granted EUA for the test in May. It's the first protein-based antigen test to receive EUA from the FDA and is for the qualitative detection of a nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimens.
Quidel said it has been awarded $71 million.
The Talis One COVID-19 point of care test is a multiplexed cartridge used with the firm's compact Talis One instrument. The test detects SARS-CoV-2 through isothermal amplification of viral RNA and an optical detection system, returning results in less than 30 minutes.
Talis said it will receive $25 million from the NIH.
Mesa's Accula test employs a handheld 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. The test is designed for the qualitative visual detection of nucleic acid from the SARS-CoV-2 virus in combined throat swab and nasal swab specimens. Mesa received EUA from the FDA for the test in March.
Mesa said it has been awarded $15.4 million.
Lab-based tests
The four lab-based tests receiving funding from the NIH include assays from Ginkgo Bioworks, Helix, Fluidigm, and Mammoth Biosciences. Helix said it will receive $33.4 million from the NIH, and Fluidigm said it will receive $37 million from the NIH. Gingko said its contract is worth a maximum of about $40 million, depending on the completion of certain technical milestones. Mammoth declined to disclose the amount of its award, but taking the worth of all the other contracts into account leaves about $26.9 million unaccounted for.
Ginkgo and Helix seem to be providing so-called mega-lab services through RADx — end-to-end test systems that include sample collection and processing in high-complexity labs, fast turnaround times, and return of results to the ordering entities.
Ginkgo is using significant automation for handling samples and high-throughput NGS technologies to process tens of thousands of individual tests at once, the NIH said. The company is working with universities, schools, public and private companies, and local communities to provide end-to-end sample collection and report results within 24 to 48 hours from sample receipt. Ginkgo is expected scale up to 50,000 tests per day in September and 100,000 per day by the end of the year, the agency added.
In May, the company received a $70 million investment from Illumina and current investors, General Atlantic and Viking Global Investors, to build large-scale sequencing-based coronavirus testing infrastructure. Ginkgo said it was building an epidemic monitoring and diagnostic testing facility in its Boston Seaport labs and was developing processes that used Illumina's NGS technology for large-scale testing, whole-genome sequencing, and environmental monitoring.
Under its contract with the NIH, 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 immediately, and within 24 to 48 hours, in very high volumes, using a combination of automation processes and NGS technologies. Helix is expected to process up to 50,000 samples a day by end of September and 100,000 samples per day at the end of the year, the agency said.
The company was also granted EUA from the FDA for a PCR-based SARS-CoV-2 test at the end of July. The Helix COVID-19 Test is designed to detect the SARS-CoV-2 nucleocapsid, ORF1ab, and spike protein genes in upper respiratory specimens. RNA extraction is performed using Thermo Fisher Scientific's MagMax Viral/Pathogen II Nucleic Acid Isolation Kit, and the test runs on Thermo Fisher's QuantStudio 7 Flex Quantitative RT-PCR instrument.
The Fluidigm 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, the NIH said. Because there are many existing Fluidigm instruments in clinical and research labs throughout the US, the agency believes that scale up and deployment of the integrated fluidic chips can provide tens to hundreds of thousands of new tests per day in the fall.
Fluidigm said in March that it was collaborating with a consortium of medical schools led by the Icahn School of Medicine at Mount Sinai to develop an epigenetic test on its microfluidics platform, for the early detection of SARS-CoV-2 infection. Using the Biomark HD system and microfluidics technology, the partners were planning to develop integrated fluidic circuits that could screen 192 samples across 24 different parallel processed assays, potentially generating more than 6,000 individual test results per day with just one hour of hands-on time.
Mammoth's SARS-CoV-2 DETECTR assay uses CRISPR, which provides a simpler workflow and significantly faster turnaround time compared to conventional PCR tests. The high-throughput solution can result in a multi-fold increase in testing capacity in commercial laboratories, the NIH said.
In April, researchers led by the University of California, San Francisco's Charles Chiu and Mammoth Biosciences Chief Technology Officer Janice Chen said they had developed a diagnostic assay for SARS-CoV-2 based on the DETECTR platform, that could be run in 30 to 45 minutes with the same sensitivity and specificity as qRT-PCR tests. The test received EUA from the FDA earlier this month.
Mammoth also announced in May that had signed a collaboration deal with the consumer healthcare arm of pharmaceutical company GlaxoSmithKline to develop at-home and point-of-care version of the test.