MicroGEM granted Emergency Use Authorization from FDA for fast point of care PCR COVID-19 saliva test
SARS-CoV-2 Saliva Test provides PCR results at the point of care in just 27 minutes and is robust with existing variants
28 Apr 2022
MicroGEM US Inc., a Virginia-based molecular biology company, has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, 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 FDA emergency use authorized saliva test for SARS-CoV-2 using PCR directly at the point of care where people can wait for fast results after providing a sample. Clinically tested during both the Delta and Omicron waves of the pandemic, the MicroGEM Sal6830 SARS-CoV-2 Saliva Test has proven to be robust through the viral mutations that have occurred.
"The MicroGEM Sal6830 SARS-CoV-2 Saliva Test will be an essential testing tool in our ongoing 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 step in our mission to democratize molecular diagnostics by moving ultra-fast, high-performance testing out of laboratories and closer to people at the point of need, thus allowing decisions to be made 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 up 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, COVID-19 testing and vaccines, and other medical services regardless of ability to pay or insurance status. "The ability to reliably and quickly test all patients who present with COVID-19 symptoms is a game-changer for our clinics, allowing us to ensure care for people at the moment they need it."
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is easy to operate. Its simple workflow and easy saliva collection reduce the workload for 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 both the Delta and Omicron waves, the multiple SARS-CoV-2 gene targets allow for robust detection of current variants and protect against obsolescence from future variants.
- Portable: The platform's small size is easily incorporated at testing sites such as mobile testing labs, ambulatory surgical centers, emergency departments, and CLIA-waived testing sites at the workplace.
"We see many patients who are anxious about nasal swabs so we are excited about the opportunity to offer saliva testing. If patients are comfortable providing the sample and quickly get their results, 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 managed practice providing medical, dental, and vision healthcare in southwest Virginia. "The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is also a nice fit for our mobile labs with a workflow easily administered by our staff, giving us the ability to provide care to patients within minutes of results."
The MicroGEM Sal6830 Point of Care PCR System's innovative cartridge design allows new targets to be added or replaced quickly, significantly reducing both assay and product development time. The company's plans include seeking authorization to expand the test menu and ruggedize the system to address austere field conditions presented in military and disaster medicine. Plans are also underway to adapt the system for the fast-growing precision medicine healthcare market with quantitative gene expression panels used as biomarkers.
In addition to facilities in Charlottesville, Virginia, MicroGEM has established a U.S.-based supply chain, with large-scale test kit production facilities in Ogden, Utah, and instrument production facilities in Hudson, New Hampshire.
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid form SARS-CoV-2 , not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the declaration is terminated or authorization is revoked sooner.
The MicroGEM Sal6830 Point of Care PCR System and the MicroGEM Sal6830 SARS-CoV-2 Saliva Test have been funded in part by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADx®) initiative to expedite 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 No. 75N92020C00015.
MicroGEM democratizes molecular biology by moving complex molecular biology tools out of highly skilled laboratories to non-laboratory settings where they can be used quickly at the point of need. The company's innovative enzymatic approach to nucleic acid extraction provides the foundation for fast sample preparation suitable for PCR analysis. Coupled with its expertise in microfluidics and synthetic biology, MicroGEM is creating the next generation of person-portable diagnostic devices for the management of infectious diseases and other personalized medicine applications.
To learn more about the MicroGEM Sal6830 SARS-CoV-2 Saliva Test visit https://microgembiocovid19.com/contact/
