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MicroGem Gets FDA Emergency Use Authorization for Saliva-Based, POC PCR COVID-19 Test

NEW YORK – Diagnostics instrument and reagent developer MicroGem announced on Tuesday that it has obtained Emergency Use Authorization from the US Food and Drug Administration for a rapid point-of-care PCR instrument and COVID test.

The portable, fully automated test system performs RT-PCR from saliva samples to provide results in 27 minutes.

Called the MicroGem Sal6830 SARS-CoV-2 Saliva Test, the test was clinically evaluated during the Delta and Omicron waves of the pandemic and has proven to be robust to viral mutations, MicroGem said in a statement.

"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," said Jeff Chapman, MicroGem's CEO.

The MicroGem Sal6830 Point of Care PCR system uses a cartridge design that allows new targets to be added or replaced quickly, "significantly reducing both assay and product development time," according to the firm.

The Charlottesville, Virginia-based company said it plans to seek authorization to expand the test menu, make the system rugged to address field conditions presented in military and disaster medicine, and adapt the system for the precision medicine healthcare market with quantitative gene expression panels used as biomarkers.

MicroGem was awarded $40.9 million from the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) initiative in 2020 to develop its technology for rapid SARS-CoV-2 testing. It also 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.