The NIH has awarded a total $129.3 million in scale-up and manufacturing support to nine additional developers of COVID-19 diagnostic tests through its Rapid Acceleration of Diagnostics (RADx) initiative, with the aim of multiplying the nation’s testing capacity.

The latest funding, announced yesterday, brings to $378 million the total value of contracts awarded through RADx toward a total 16 developers toward advanced COVID-19 diagnostics.

Funded by NIH in the latest round of RADx awards were three developers of point-of-care tests:

• MatMaCorp (Lincoln, NE) for a portable mini-lab designed to rapidly perform multiple RT-PCR assays in a single platform. The technology can be used with multiple sources of reagents and is targeted for community hospitals and clinics in underserved, rural populations.
• Maxim Biomedical (Rockville, MD) for a single-use, lateral-flow test strip immunoassay designed to offer results in 15 minutes or less. The assay can be performed without an instrument for reading and does not require any specialized equipment.
• MicroGEM International (Charlottesville, Virginia) for a portable, point-of-care device designed to detect SARS-CoV-2 in saliva samples using RT-PCR in 15 minutes. The test uses a microfluidic cartridge with the potential for simultaneous detection of multiple pathogens such as influenza.

Through RADx, the NIH also funded five developers of lab-based tests:

• Aegis Sciences (Nashville, TN) for a novel coronavirus nucleic acid detection kit and distribution system for high throughput testing using nasal and oral swab samples, as well as a multiplexed SARS-CoV-2 + Flu A/B assay by early October. Aegis recently quadrupled its COVID-19 testing capacity to 15,000 samples per day, and plans to quadruple that total to 60,000 samples per day by September 30, through a $6.6 million NIH grant. After receipt of samples, the tests are intended to return results in 24 hours or less on average.

• Broad Institute of MIT and Harvard (Cambridge, MA) for scale-up of a high-throughput RT-PCR COVID-19 viral test using specimens from nasal swabs. The Broad already performs tests for more than 530 regional hospitals, nursing homes, shelters, community health centers, senior living facilities, and state and city collection sites in vulnerable communities. The award will help quadruple The Broad’s testing capacity from 25,000 to 100,000 tests per day, the NIH said.

• Ceres Nanoscience (Manassas, VA) for a sample prep method using Nanotrap particles that extracts and concentrates viral material to reduce processing time and improve sensitivity. The method can be used on testing platforms that range from point-of-care systems to high-throughput laboratory processes, in order to improve speed and performance by 2- to 10-fold. 

• Illumina (San Diego) for scale-up of automated sample processing and next-generation sequencing technology for COVID-19 testing. Upon receipt of samples at the laboratory, Illumina can process results for its Illumina COVIDSeq test within 24 hours. Illumina’s high-throughput capacity can be expanded to 48,000 tests per day. 

• PathGroup (Nashville, TN) for adding additional instrumentation and automation through partnerships with Illumina, LGC, and Thermo Fisher Scientific to increase the daily number of COVID-19 tests performed to 80,000 by December 2020. PathGroup now processes about 10,000 COVID-19 RNA tests a day using Roche 6800 and Hologic Panther instruments. PathGroup says it has infrastructure in place in 20 states throughout the U.S. Southeast and Midwest.

• Sonic Healthcare (Sydney; U.S. headquarters in Austin, TX) for an expanded scope and expedited timeline of a framework for large-scale COVID-19 RT-PCR testing platforms and distribution capacity. Using specimens from predominantly nasal swabs, Sonic plans to continue adding capacity to reach about 166,000 samples tested per day with new high-throughput technology. Sonic said it can simultaneously deploy multiple test platforms and methodologies, through its network of regional testing hubs located in various clinical settings and geographic areas.

According to data compiled by The COVID Tracking Project, a volunteer organization launched by The Atlantic to collect and publish COVID-19 testing data, a total 644,842 tests were carried out on Wednesday, bringing the nation to a total 6,072,291 confirmed plus probable cases of the virus. The number of deaths stood at 177,669, while 35,569 Americans were hospitalized as of Wednesday.

The number of COVID-19 tests carried out per day over the past two weeks has ranged from a low of 634,156 on August 25, to a high of 772,256 three days later, the Tracking Project found.

The NIH launched RADx in April, using a $1.5 billion emergency supplemental appropriation from Congress, with the goal of making millions of COVID-19 tests available each week, by the fall. In July, the NIH issued RADx’s initial awards totaling $248.7 million to seven developers of SARS-CoV-2 diagnostics.

“Diagnostic testing is a critical component of the nation’s strategy to meet the challenge of the COVID-19 pandemic,” NIH Director Francis S. Collins, M.D., Ph.D., said in a statement “The RADx initiative has moved swiftly to speed innovation and later-stage development in the biomedical technology sector. The results thus far have been outstanding.”

Some of the technologies being funded through RADx have also received support from the Biomedical Advanced Research and Development Authority (BARDA), within the Department of Health and Human Services; and by the Defense Advanced Research Projects Agency (DARPA), within the Department of Defense.

“The new technologies being funded today have the potential to transform the diagnostics landscape if their promise is proven in clinical studies,” added Adm. Brett P. Giroir, Assistant Secretary for Health. “This all-of-government approach to testing innovation including DARPA, BARDA, NIH, HHS, and the private sector will yield benefits not only for the current pandemic, but for diverse acute and chronic diseases Americans fight every day.”