NEW YORK – With a recent US Emergency Use Authorization for its saliva-based test for SARS-CoV-2, rapid molecular diagnostics developer MicroGEM is working on growing the market for its new RT-PCR system.

Founded in 2016, Charlottesville, Virginia-based MicroGEM's core technologies incorporate flagship thermophilic enzymes from its collection of extremophiles originally discovered in Antarctica.

The firm's fully automated RT-PCR instrument, called the MicroGEM Sal6830 Point of Care PCR System, performs molecular testing in less than 30 minutes. It employs nanoparticle-mediated cell capture, high temperature lysis, and MicroGEM's extremophile enzymes. It u tilizes microfluidics-based cartridges with eight wells, with high temperature replacing pumps as the driving force for the microfluidic flow. The combined result is a rugged system with few moving parts.

The Sal6830 was granted EUA from the US Food and Drug Administration in April for use in CLIA-waived settings along with a saliva-based SARS-CoV-2 test.

Lianne Landers, senior director of corporate communications at MicroGEM, noted in an email that the Sal6830 illustrates the firm's core mission "to bring person-portable technologies to the point of need, especially in the personalized medicine and infectious disease sectors."

MicroGEM's foundational extraction process "enables fast RNA extraction and PCR," Landers said, adding that plans are underway to expand the test menu and further ruggedize the system for remote testing locations, as well to as adapt it for the precision medicine market.

The system was purpose-built for point-of-care use. As part of the CLIA-waived status, it requires no technical training to operate, and the touch screen walks a user through the hands-on steps before the test cartridge is inserted into the system. And, for the COVID saliva test, "sample collection requires minimal hands-on steps and takes less than three minutes," Landers said.

Once a test cartridge is loaded into the SAL6830, integrated sample prep means there are no additional liquid handling steps, and the time to result is 27 minutes from the moment the "start test" button is pressed.

Landers said the SAL6830 instrument costs $8,500 to purchase outright, but can also be incorporated as an operating lease or system rental. It has a cost per test of $40 and tests are sold in kits of 30.

The system is approximately 16 inches wide, 14 inches deep, 16 inches tall, and weighs about 33 pounds. As such, it is a bit too large to be easily carried around, but MicroGEM also offers a Mobile  Workstation on its website that includes a cart with storage and optional battery power for use when electricity is not available.

MicroGEM was previously awarded $40.9 million from the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) initiative in 2020 to develop its rapid SARS-CoV-2 test. It subsequently acquired New Hampshire-based Jump Start Manufacturing in 2021, opened a large-scale test kit production facility in Ogden, Utah, and established a US-based supply chain to support test system production. The firm currently has a production capacity of 4 million COVID-19 tests per month.

A growing number of rapid, portable PCR systems have been launched during the SARS-CoV-2 pandemic including handheld and disposable options.

Integrated benchtop PCR systems currently in development or commercially available are numerous. These include the Roche Cobas Liat, Meridian Revogene, Credo VitaPCR, Binx io, QuantumDx Q-POC, Genomadix Cube, Anitoa Maverick, Scope Fluidics PCR One, OnSiteGene XDive, Fluxergy Analyzer, Minute Molecular DASH, and the Quidel Savanna.

Some instruments, like the DiaSorin Molecular Liaison MDx, require a separate prep step but can run selected tests directly from sample, while other instruments, like Qiagen's QiaStat-Dx, the CLIA-waived version of the BioMé rieux BioFire FilmArray, or the CLIA-waived Cepheid Xpert Xpress are designed to perform multiplex panels and be wheeled to the point of care on a cart or used in decentralized lab spaces.

Of the aforementioned systems, some are CLIA waived for use at the point of care for nasal or nasopharyngeal swab testing rather than saliva, while others can test from saliva but are not CLIA waived. Landers noted that the MicroGEM system and test are special in that they tick both boxes.

For the newer variants of SARS-CoV-2, saliva may actually be a preferred sample type compared to nasal or nasopharyngeal swabs, she said, adding that this "has been even more the case for the Omicron variant … because of the way that the virus is replicating."

Saliva testing is also "much more pleasant for the person taking the test," Landers added.

The fully integrated sample prep is also technologically different from other systems — involving capture of intact virus from saliva, lysis and extraction of the virus, purification of the extract, and automatic transfer to a series of PCR chambers for RT-PCR — as is the fact that it can perform PCR from intact viral particles rather than viral debris, Landers noted.

The virus particle capture step serves to leave the viral debris behind prior to nucleic acid extraction, Landers explained, enabling the identification of patients more likely to be infectious and reducing latent positive PCR results after recovery.

MicroGEM has approximately 250 employees worldwide. Most of the workforce is in the US, with headquarters in Charlottesville and manufacturing operations in Utah and New Hampshire, but the firm also has operations in New Zealand, China, and the UK. It is currently expanding its employee headcount in all locations and has expanded its C-suite in recent years, Landers said.

President and CEO Jeff Chapman, a former director of global marketing and scientific alliances for Beckman Coulter, joined the company in October 2018 and is supported by a senior leadership team with 11 members. CSO David Saul joined MicroGEM when it was founded in 2016, while CFO Stuart Hellyar and Chief Commercial Officer LeRoy Blake joined in 2018 and 2019, respectively. Last year, MicroGEM also brought on Chief Technology Officer Thomas Moran with the Jump Start Manufacturing acquisition.

Going forward, MicroGEM plans to expand the menu for the SAL6830 to include both qualitative and quantitative tests and assays for other sample types such as nasopharyngeal swabs, blood, urine, and tissue, Landers said. "The system was designed to rapidly adapt to future infectious disease outbreaks and other healthcare issues," she added.

Landers did not provide a precise number of system placements so far but said the firm has placed the SAL6830 in locations "where it is imperative to have fast, accurate results at the point of care to avoid business shutdowns and spread," like walk-in clinics, mobile testing sites, and government agencies.

MicroGEM is also seeing opportunities in locations where lab-based testing isn't readily available or has a slow turnaround time, such as rural sites or in vulnerable communities.

In the meantime, MicroGEM maintains a core business in extraction reagents for nonclinical use, such as for microbiology, plant biology, and forensics applications.

Using its extremophile enzymes, the reagents engender a single-tube approach that can speed up extractions, reduce contamination, decrease manual steps, and minimize loss of DNA and RNA without the use of detergents or chaotropic salts.

"SARS-CoV-2 is one example of our extraction's utility," Landers said. "We consider the businesses complimentary," she added, noting the firm will continue to provide researchers with the extraction tools they need to conduct their studies but will also "have a laser focus" on the mission to bring point-of-need technologies to people who need them.

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