MicroGEM US, a Virginia-based molecular biology company, has been granted Emergency Use Authorisation (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 authorised 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.
MicroGEM CEO Jeff Chapman said: “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. The introduction of the MicroGEM Sal6830 Point of Care PCR System marks a historic step in our mission to democratise 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 Point of Care PCR System’s cartridge design allows new targets to be added or replaced quickly, reducing both assay and product development time. The company’s plans include seeking authorisation 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 authorised for emergency use by FDA under an EUA for use by authorised laboratories. This product has been authorised 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 authorised for the duration of the declaration that circumstances exist justifying the authorisation of emergency use of in vitro diagnostics for 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 authorisation 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 and Department of Health and Human Services.
