Shutterstock / Angel Soler Gollonet

A portable, reverse transcription polymerase chain reaction (RT-PCR) device that requires no lab processing for results and a paper-based lateral flow immunoassay that operates similarly to a home pregnancy test are among nine new technologies that have joined the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative. NIH recently announced $129.3 million in scale-up and manufacturing support for these SARS-CoV-2 tests, whose aim is to deliver results at the point-of-care (POC), within a day’s time.

“Diagnostic testing is a critical component of the nation’s strategy to meet the challenge of the COVID-19 pandemic,” said NIH Director Francis S. Collins, MD, PhD, in a news release. “Just started at the end of April, 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.”

The nine awardees are:

Point-of-care tests

MatMaCorp, Lincoln, Nebraska

The company’s COVID-19 2SF is a two-step RT-PCR-based isothermal amplification and fluorescent detection assay. Primers and probes help detect RNA from SARS-CoV-2, as well as human internal positive control (HIPC) RNA, in nasopharyngeal swab specimens. The test includes a specific amplification step followed by probe detection to ensure accurate results and reduce the risk for false positives. All reagents are lyophilized and stored at ambient temperature, so no refrigeration is needed. The test is >99% inclusive for all SARS-CoV-2 isolate sequences and is not expected to cross-react with other coronaviruses or respiratory pathogens. The total run time is 2 hours—developers said they can call a strong positive in about 60 minutes. MatMaCorp, which received nearly $1.4 million from NIH, is awaiting notification from the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for its test.

Maxim Biomedical, Rockville, Maryland

Maxim received an award of $5.2 million to scale up a single-use, lateral-flow test strip immunoassay. The test has a simple and streamlined workflow that allows for incubation, reading, and disposal in one tube, producing results in less than 15 minutes. “We’ve developed a compact and closed-tube format for the swab specimen, reagents, and test strip that aims to reduce the risk of exposure to healthcare workers and patients,” Jonathan Maa, the company’s chief operating officer, told CLN Stat. Maxim is collaborating with NIH and the U.S. Department of Defense to file for an FDA EUA. With the support of RADx, “we expect to be able to manufacture and distribute greater than 15 million tests per month in early 2021,” said Maa.

MicroGEM International, Charlottesville, Virginia

MicroGEM received $40.9 million to develop a portable POC test that delivers results in 15 minutes. Real-time RT-PCR technology identifies SARS-CoV-2 in saliva, simultaneously with influenza types A and B. Nonmedical staff can use this test at the POC without a lab to process results. “Based on patented enzymatic RNA extraction technology, the system is a simple approach to quickly detecting and managing infectious disease,” the company said in a statement.

Lab-based tests

Aegis Sciences, Nashville, Tennessee

The company plans to use its $6.6 million award to scale up two different types of assays. One of the tests, a molecular diagnostic nasal swab assay, uses RT-PCR to detect 400 copies of SARS-CoV-2 virus in a milliliter of sample. Aegis had a goal of achieving 60,000 samples per day by September 30, with plans to deploy a multiplexed SARS-CoV-2 + Flu A/B assay by early October. On average, these tests should return results in 24 hours.

Broad Institute, Cambridge, Massachusetts

This high-throughput RT-PCR testing platform uses the N2 target of the SARS-CoV-2 viral genome as well as a human control—so it’s a “two well” assay, according to Stacey Gabriel, senior director of the genomics platform at the Broad Institute. FDA granted an EUA to the platform in July. So far, the institute has produced 1.5 million tests—an average of 65,000 tests per day—making its testing capability available throughout New England and to some national reference labs. “We intend to get to 100,000 tests per day by October” through NIH’s $14.5 million grant, Gabriel told CLN Stat.

Ceres Nanoscience, Manassas, Virginia

Nanotrap Magnetic Virus Particles are magnetic hydrogel particles that capture and concentrate from patient samples viruses like SARS-CoV-2 and influenza. The particles improve RNA extraction time by two- to fourfold and the downstream assay’s limit of detection by two- to tenfold. Nanotrap particles are compatible with multiple types of testing downstream assays, including respiratory virus multiplex assays. Diagnostic companies have been incorporating Nanotrap particles into POC systems and into high-throughput laboratory-developed tests for SARS-CoV-2. “The manufacturers of those test systems will be seeking authorization from the FDA for the entire test system, including the use of Nanotrap particles. We expect to have multiple customers receive EUAs from the FDA in 2020,” Robbie Barbero, PhD, chief business officer of Ceres Nanosciences, told CLN Stat.  

Illumina, San Diego, California

Illumina received $12.3 million from NIH to ramp up capacity for its COVIDSeq test to 48,000 tests per day. The test, which received an EUA, uses automated sample processing and next-generation sequencing (NGS) technology to produce results in 24 hours. “For most positive samples, a full-length SARS-CoV-2 sequence will also be developed for research purposes. In addition to helping increase U.S. diagnostic capacity, the service will generate thousands of viral sequences. This will be increasingly important as the virus continues to evolve and vaccines come into clinical use,” the company said in a statement.

PathGroup, Nashville, Tennessee

The company uses Roche 6800 and Hologic Panther instruments to produce about 14,000 COVID-19 RNA tests a day. Its testing infrastructure spans 20 states throughout the Southeast and Midwest regions. PathGroup plans to use its $20.7 million award to expand the company’s SARS-CoV-2 testing lab to produce about 80,000 tests per day, delivering results in 24 hours. To make this happen, PathGroup has partnered with Thermo Fisher, LGC, and Illumina to deploy additional instrumentation and automation technology.

Sonic Healthcare USA, Austin, Texas

Sonic received a $20.7 million award to expand the company’s COVID-19 RT-PCR testing platforms to 166,000 tests per day at nine of its high-throughput laboratory testing locations. Sonic’s testing network simultaneously deploys multiple test platforms and methodologies, using specimens mostly from nasal swabs. The NIH funds will specifically target access to underserved communities. “The RADx initiative complements Sonic’s current commitment to prioritize services to the most vulnerable and high-risk patients. Servicing these populations will continue to be a central part of our testing strategy,” the company said in a news release.

This is NIH’s second round of RADx awards. On July 31, the program awarded $248.7 million in contracts to seven companies, whose technologies leveraged NGS, CRISPR, nucleic acid, and viral antigen platforms to identify the virus. All of the awardees have a goal of scaling up and deploying tests starting this fall, as flu season begins. RADx is one of several programs underway by the agency to promote and scale up SARS-CoV-2 testing. A year-end goal is to make tests available to 6 million Americans (2% of the population) on a daily basis.