MicroGEM Obtains Emergency Use Authorization from FDA


SARS-CoV-2 saliva test provides point-of-care PCR results in just 27 minutes and is robust with existing variants

MicroGEM US Inc., a Virginia-based molecular biology company, has obtained Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for the MicroGEM Sal6830 SARS- CoV-2, which provides polymerase chain reaction (PCR) results at the point of care in 27 minutes.

The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is the first saliva test cleared for emergency use by the FDA for SARS-CoV-2 using point-of-care PCR where people can expect fast results after providing a sample. Clinically tested during the Delta and Omicron waves of the pandemic, the MicroGEM Sal6830 SARS-CoV-2 Saliva Test has been shown to be robust despite the viral mutations that have occurred.

“The MicroGEM Sal6830 SARS-CoV-2 Saliva Test will be a critical testing tool in our continued efforts to get our nation’s communities and businesses back to regular operations,” said MicroGEM CEO Jeff Chapman. “The introduction of the MicroGEM Sal6830 Point of Care PCR System marks a historic milestone in our mission to democratize molecular diagnostics by moving ultra-fast, high-performance testing out of the lab and closer to people at the point of need, enabling decisions to be done in real time.”

“The MicroGEM Sal6830 SARS-CoV-2 saliva test will be an invaluable tool for testing children without scaring them with a stick in their nose.” said Vanessa Mills, RN, BSN, MPH and COO of Care 4 U (C4UCHC), a Miami, Florida-based community health center providing primary medical care, including HIV/STD screening, testing and COVID-19 vaccines, and other medical services regardless of ability to pay or insurance status. “The ability to reliably and quickly test all patients who show symptoms of COVID-19 is a game-changer for our clinics, allowing us to provide care to people when they need it.”

The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is easy to use. Its simple workflow and easy saliva collection reduce the workload of healthcare workers and limit their exposure to the sample.

Additional benefits include:

  • Non invasive : Requiring only a small amount of saliva, it eliminates the discomfort of swab testing, making it more comfortable for routine testing.
  • Robust with existing variants: Clinically tested during Delta and Omicron waves, multiple SARS-CoV-2 gene targets enable robust detection of current variants and protect against obsolescence of future variants.
  • Portable: The platform’s small size fits easily into testing sites such as mobile testing labs, ambulatory surgery centers, emergency departments, and workplace CLIA-exempt testing sites.

“We see many patients worried about nasal swabs, so we are delighted to be able to offer saliva testing. If patients are comfortable providing the sample and getting their results quickly, then they are more likely to ‘be receptive to ongoing care and future testing.'” said Dr. Teresa Tyson, DNP, MSN, FNP-BC, FAANP, president and CEO of The Health Wagon, a nurse practitioner-run practice providing medical, dental and vision care in southwestern Virginia. “The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is also a perfect fit for our mobile labs with a workflow easily administered by our staff, allowing us to provide patient care within minutes of results.”

The innovative cartridge design of the MicroGEM Sal6830 Point of Care PCR System allows new targets to be quickly added or replaced, significantly reducing assay and product development time. The company’s plans include seeking permission to expand the testing menu and harden the system to deal with the austere field conditions presented in military and disaster medicine. Plans are also underway to adapt the system to the growing healthcare market of precision medicine with quantitative gene expression panels used as biomarkers.

In addition to facilities in Charlottesville, Virginia, MicroGEM has established a US-based supply chain, with full-scale test kit production facilities in Ogden, Utah, and production facilities for instruments in Hudson, New Hampshire.

The MicroGEM Sal6830 SARS-CoV-2 Saliva Test has not been cleared or approved by the FDA, but has been cleared for emergency use by the FDA under an EUA for use by licensed laboratories . This product has been licensed for the detection of SARS-CoV-2 nucleic acid form only, and not for other viruses or pathogens. Emergency use of this product is authorized only for the duration of the declaration that there are circumstances justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID -19 pursuant to Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 USC § 360bbb-3(b)(1), unless the statement is terminated or the authorization is revoked earlier.

The MicroGEM Sal6830 Point of Care PCR System and MicroGEM Sal6830 SARS-CoV-2 Saliva Test were funded in part by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADx®) initiative to accelerate the launch of the test with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under contract number 75N92020C00015.

MicroGEM democratizes molecular biology by moving complex molecular biology tools from highly skilled labs to non-lab environments where they can be used quickly when needed. The company’s innovative enzymatic approach to nucleic acid extraction provides the basis for rapid sample preparation suitable for PCR analysis. Coupled with its expertise in microfluidics and synthetic biology, MicroGEM creates the next generation of portable diagnostic devices for infectious disease management and other personalized medicine applications.

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